Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products, 3638-3654 [2023-00922]
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
of Food and Drugs, 21 CFR part 886 is
amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 886—OPHTHALMIC DEVICES
Food and Drug Administration
1. The authority citation for part 886
continues to read as follows:
21 CFR Parts 1000, 1002, 1010, 1020,
1030 and 1050
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
[Docket No. FDA–2018–N–3303]
■
2. Add § 886.5201 to subpart F to read
as follows:
■
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§ 886.5201 Intense pulsed light device for
managing dry eye.
(a) Identification. An intense pulsed
light device for managing dry eye is a
prescription device intended for use in
the application of intense pulsed light
therapy to the skin. The device is used
in patients with dry eye disease due to
meibomian gland dysfunction, also
known as evaporative dry eye or lipid
deficiency dry eye.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Clinical performance testing must
evaluate adverse events and
improvement of dry eye signs and
symptoms under anticipated conditions
of use.
(2) Thermal safety assessment in a
worst-case scenario must be performed
to validate temperature safeguards.
(3) Performance testing must
demonstrate electrical safety and
electromagnetic compatibility (EMC) of
the device in the intended use
environment.
(4) Software verification, validation,
and hazard analysis must be performed.
(5) The patient-contacting
components of the device must be
demonstrated to be biocompatible.
(6) Physician and patient labeling
must include:
(i) Device technical parameters;
(ii) A summary of the clinical
performance testing conducted with the
device;
(iii) A description of the intended
treatment area location;
(iv) Warnings and instructions
regarding the use of safety-protective
eyewear for patient and device operator;
(v) A description of intense pulse
light (IPL) radiation hazards and
protection for patient and operator;
(vi) Instructions for use, including an
explanation of all user interface
components; and
(vii) Instructions on how to clean and
maintain the device and its components.
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01049 Filed 1–19–23; 8:45 am]
BILLING CODE 4164–01–P
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Radiological Health Regulations;
Amendments to Records and Reports
for Radiation Emitting Electronic
Products; Amendments to
Performance Standards for Diagnostic
X-ray, Laser, and Ultrasonic Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, Agency, or we) is
amending and repealing parts of the
radiological health regulations covering
recommendations for radiation
protection during medical procedures,
certain records and reporting for
electronic products, and performance
standards for diagnostic x-ray systems
and their major components, laser
products, and ultrasonic therapy
products. The Agency is taking this
action to clarify and update the
regulations to reduce regulatory
requirements that are outdated and
duplicate other means to better protect
the public health against harmful
exposure to radiation emitting
electronic products and medical
devices.
DATES: This rule is effective February
21, 2023.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Robert Ochs, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3680, Silver Spring,
MD 20993, 301–796–6661, email:
Robert.Ochs@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of Major Provisions of the
Final Rule
C. Legal Authority
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D. Costs and Benefits of the Final Rule
II. Table of Abbreviations/Commonly Used
Acronyms
III. Background
A. Need for Amendments and Repeal of
Certain Radiological Health Regulations
B. Summary of Comments to the Proposed
Rule
C. General Overview of Final Rule
IV. Legal Authority
V. Comments to the Proposed Rule and
FDA’s Responses
A. General Comments on the Proposed
Rule
B. Radiation Safety Recommendations/
Standards Comments
C. General Format and Edit Comments
D. Records and Reports Comments
E. Reports of Assembly, Forms, and
Guidance Comments
F. Accidental Radiation Occurrences
Comments
G. Laser Comments
VI. Effective Date
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
C. Summary of Regulatory Flexibility
Analysis
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule amends and repeals
certain regulations for radiation emitting
electronic products and medical devices
because the FDA has identified the
regulations as being outdated and
duplicative of other means for reducing
radiation exposure to the public. The
Agency is updating the regulations to
amend or repeal regulations that are
outdated and otherwise clarify
requirements for protecting the public
health against radiation exposure from
specific electronic products and medical
devices. The regulations being finalized
for amendment or repeal are the
radiation protection recommendations
for specific uses, records and reporting
requirements for electronic products,
applications for variances, and
performance standards for diagnostic xray systems and their major
components, laser products, and
ultrasonic therapy products.
B. Summary of the Major Provisions of
the Final Rule
This final rule updates FDA’s
radiological health regulations to amend
or repeal the following provisions:
• Repeal the radiation protection
recommendations that have become
outdated and unnecessary;
• Removing or reducing some of the
annual reports and test record
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requirements that are unnecessary or
may be duplicative of other reporting
requirements by FDA and State
regulators;
• Revise the timing for submissions of
reporting requirements for accidental
radiation occurrences (AROs) to provide
for quarterly reporting for AROs that are
not associated with a death or serious
injury;
• Amend the applications for
variances processes to no longer require
a manufacturer to submit two additional
copies with the original documents;
• Amend the regulations to no longer
require assemblers who install certified
components of diagnostic x-ray systems
to submit reports of assembly to the
Agency;
• Amend the reporting requirements
for manufacturers that incorporate a
certified laser product to reduce
reporting that is considered duplicative
under certain conditions; and
• Repeal the performance standard
for ultrasonic products because it is
limited to a subset of physical therapy
devices with an outdated standard.
D. Costs and Benefits of the Final Rule
amending parts of the general
provisions including records and
reporting requirements for electronic
products. Benefits are estimated in
terms of cost savings. Industry cost
savings are derived by estimating the
savings in reduced labor resulting from
the reduction in reporting,
recordkeeping, and third-party
disclosure requirements. Cost savings to
FDA result from the reduction in labor
hours required to review reports. The
total present value cost savings over a
20-year time period are $69.71 million
at a 7 percent discount rate and $97.89
million at a 3 percent discount rate.
Annualized total cost savings are $6.58
million. We estimate the costs to read
the rule for all reporting respondents.
The present value costs are $1.60
million and the annualized costs
calculated over a 20-year time period
are $0.14 million at a 7 percent discount
rate and $0.10 million at a 3 percent
discount rate.
This final rule updates FDA’s
radiological health regulations by
II. Table of Abbreviations/Commonly
Used Acronyms in This Document
The Agency believes the amendments
and repeals will help to ensure that the
requirements for radiation emitting
electronic products and devices will
continue to protect the public health
and safety while reducing regulatory
burdens.
C. Legal Authority
FDA is issuing this final rule under
the same authority under which FDA
initially issued these regulations, the
device and general administrative
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act). FDA has
the authority under the FD&C Act to
amend the performance standard for
diagnostic x-ray systems and their major
components, amend the performance
standard for laser products, and repeal
radiation protection recommendations
and the performance standard for
ultrasonic therapy products, as provided
for in this rule.
Abbreviation
What it means
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ARO ..................................................
CDRH ...............................................
CFR ..................................................
CRCPD .............................................
CT .....................................................
EO ....................................................
EPRC ................................................
EPA ..................................................
FD&C Act .........................................
FDA, Agency or we ..........................
ICRP .................................................
IEC ....................................................
ISO ...................................................
MDR .................................................
NCRP ...............................................
OMB .................................................
PRA ..................................................
TEPRSSC .........................................
Accidental Radiation Occurrences.
Center for Devices and Radiological Health.
Code of Federal Regulations.
Conference of Radiation Control Program Directors.
Computerized Tomography.
Executive Order.
Electronic Product Radiation Control.
Environmental Protection Agency.
Federal Food, Drug, and Cosmetic Act.
Food and Drug Administration.
International Commission on Radiological Protection.
International Electrotechnical Commission.
International Organization for Standardization.
Medical Device Reporting.
National Council on Radiation Protection and Measurements.
Office of Management and Budget.
Paperwork Reduction Act of 1995.
Technical Electronic Product Radiation Safety Standards Committee.
III. Background
FDA recognizes that some records and
reporting requirements for some
radiation emitting electronic products
and medical devices are not necessary
to protect the public health and safety
in compliance with the Electronic
Product Radiation Control (EPRC)
program (see sections 532, 534(a)(1),
and 537(b) of the FD&C Act (21 U.S.C.
360ii, 360kk(a)(1), and 360nn(b))). In
addition, some of the recommended
protections against radiation and
performance standards are now
outdated and redundant to other Federal
and State requirements, including
professional guidelines that apply to the
education and licensing of practitioners,
as well numerous current radiation
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guidance documents and industry
standards that practitioners and
industry rely on to protect the public
health and safety. For example, there are
more recent standards that industry and
FDA can rely on for the safety of
ultrasonic therapy devices for physical
medicine, for instance the International
Electrotechnical Commission (IEC)
standards 60601–2–5, Medical electrical
equipment—Part 2–5: Particular
requirements for the basic safety and
essential performance of ultrasonic
physiotherapy equipment (August 6,
2013) and 61689, Ultrasonics—
Physiotherapy systems—Field
specifications and methods of
measurement in the frequency range 0.5
MHz to 5 MHz (January 30, 2014). FDA
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also recognizes that submission of
certain quarterly reports is unnecessary
given certain annual reporting
requirements. In addition, the
submission of initial product reports for
products that are also subject to
premarket authorization prior to
marketing is duplicative. The Safe
Medical Devices Act of 1990 (Pub. L.
101–629), enacted on November 28,
1990, transferred the provisions of the
Radiation Control for Health and Safety
Act of 1968 (Pub. L. 90–602) (formerly
42 U.S.C. 263b through n(i) et seq.) from
Title III of the Public Health Service Act
to Chapter V, subchapter C of the FD&C
Act, EPRC (sections 531–542 of the
FD&C Act (21 U.S.C. 360hh–360ss)).
Under these provisions, FDA
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administers the EPRC program to
protect the public health and safety.
This authority provides for developing,
amending, and administering radiation
safety performance standards for
electronic products.
FDA is responsible for protecting and
promoting the public health regarding
electronic product radiation from
medical devices and electronic
products. Voluntary consensus
standards regarding safety and essential
performance have been developed and
continually improved to increase the
safety of these devices and products
(sections 514(c) (21 U.S.C. 360d) and
531–542 of the FD&C Act). FDA believes
radiation emitting electronic products
and devices that comply with Federal
standards and Federally-recognized
consensus standards, adequately protect
the public health and safety and provide
a reasonable assurance of safety and
effectiveness, as applicable, when
properly used by trained personnel, and
concern has shifted to minimizing
improper uses. FDA, patients, health
workers, and industry recognize that
medical products that emit radiation
should be used only when medically
justified to answer a clinical question or
to guide treatment of a disease, and that
the amount of radiation used should be
limited to that necessary to accomplish
the clinical task (Refs. 1, 2–4).
In 2010, FDA’s Center for Devices and
Radiological Health (CDRH) launched
an ‘‘Initiative to Reduce Unnecessary
Radiation Exposure from Medical
Imaging’’ (Ref. 3) to protect public
health by promoting the appropriate use
of radiation and safety features to
minimize unnecessary radiation
exposure from medical imaging.
Through this initiative, FDA
collaborates with other agencies and the
healthcare professional community to
mitigate factors contributing to
unnecessary patient exposure to
radiation during medical procedures.
The range of electronic products
marketed today is diverse with regards
to radiation emission levels, product
complexity, consumer use, and sales
volume. The public risk associated with
exposure to radiation from these
products also varies significantly;
however, the risks to patients can be
mitigated by medical personnel only
performing exams using radiation when
necessary to answer a medical question,
treat a disease, or guide a procedure
(Ref. 4).
In accordance with FDA’s directive to
carry out the EPRC program (see
sections 532, 534(a)(1), and 537(b) of the
FD&C Act), FDA prescribes and amends
performance standards for electronic
products to control the emission of
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electronic product radiation when
necessary to protect the public health
and safety. In establishing performance
standards consistent with the statute,
FDA consulted with the Technical
Electronic Product Radiation Safety
Standards Committee (TEPRSSC)
(section 534(f) of the FD&C Act) (Ref. 5).
On October 26, 2016, a TEPRSSC
meeting was held and FDA presented,
for consultation with TEPRSSC,
proposed certain amendments to the
regulations for laser, sonic, x-ray, and
other radiation emitting products to best
align FDA’s focus with the public health
need and reduce or eliminate standards
or reporting that were no longer
considered necessary (Ref. 5). FDA also
proposed to the TEPRSSC the removal
of the ultrasonic therapy performance
standard with continuing reliance on
medical device review prior to
marketing authorization. Items in these
amendments have been considered in
discussions by TEPRSSC as necessary.
Therefore, FDA has determined that the
regulatory requirements can be adjusted
to take account of the wide range of
electronic products currently on the
market and focus on products that pose
a higher risk to the public.
A. Need for Amendments and Repeal of
Certain Radiological Health Regulations
Many of the requirements in our
radiological health regulations are over
30 years old. As described below and in
the proposed rule (84 FR 12147, April
1, 2019) the final rule amends and
repeals certain radiological health
regulations to reduce regulatory
requirements that are outdated and
duplicative. Specifically, this final rule
amends parts of the radiological health
regulations covering recommendations
for radiation protection during medical
procedures, certain records and
reporting for electronic products,
applications for variances, and
performance standards for diagnostic
x-ray systems and their major
components, laser products, and
ultrasonic therapy products while still
assuring the public health and safety is
protected against harmful exposure to
radiation emitting electronic products
and medical devices.
B. Summary of Comments to the
Proposed Rule
In the Federal Register of April 1,
2019, FDA published a proposed rule to
amend the radiological health
regulations (84 FR 12147). The comment
period for the proposed rule closed on
July 1, 2019. FDA received comments
on the proposed rule from several
entities including medical device
associations, industry, medical and
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healthcare professional associations,
public health advocacy groups, and
individuals. While some comments
object to particular sections or
subsections of the proposed rule, almost
all comments voice support for the
objective intent of the proposed rule, to
amend certain regulations to reduce
regulatory burden while continuing to
assure protection of the public health
and safety against harmful exposure to
radiation emitting electronic products
and medical devices.
Some comments raise concerns or
request clarification regarding:
• repealing the radiation protection
recommendations,
• removing or reducing certain
records and reporting requirements for
electronic products,
• incorporating and expanding the
policies described in FDA’s Laser Notice
42 to higher powered laser products,
• amending the performance
standards for laser products that
incorporate certified laser systems,
• information on future technologies
and other measures that may reduce or
eliminate radiation exposure,
• document retention and
responsibilities related to initial,
supplemental, abbreviated and annual
reports,
• assemblers’ responsibilities for
maintaining a record of report of
assembly on file,
• the tracking and trending analysis
related to the requirements for reports
on accidental radiation occurrences, and
• additional amendments to
performance standards for laser
products.
C. General Overview of Final Rule
FDA considered all comments
received on the proposed rule and made
changes, primarily for clarity and
accuracy and to be consistent with the
goal of reducing the burden of
regulatory requirements for radiation
emitting products and medical devices
without compromising patient safety.
On its own initiative, FDA is also
making minor technical changes to
improve clarity and consistency and
reduce regulatory burden. Based on the
comments received on the proposed
rule, FDA has made changes from the
proposed rule (84 FR 12147) to include
the following revisions in the codified
section of this final rule:
• Include the word ‘‘accidental’’ in
the definition for radiation occurrence
(§ 1000.3(a)),
• include a footnote in the records
and reports table clarifying laser
product certification (table 1 in
§ 1002.1),
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• include language of information
needed for quarterly reporting of
accidental radiation occurrences
(§ 1002.20(c)(2)(ii)),
• include a paragraph with language
to identify when certification and
reporting is duplicative and
unnecessary for laser products under
§ 1040.10 that incorporate a certified
laser system (§ 1010.2(e)),
• identify an alternative format for
identification of the month and date of
the manufacture of an electronic
product (§ 1010.3(a)(2)(ii)),
• clarify the options for submissions
for applications for variances
(§ 1010.4(b)(1)), and
• revise the title and applicability for
television receivers that contain a
cathode ray tube (§ 1020.10).
FDA also decided on its own
initiative to include the following
additional amendments to this final rule
for clarity and consistency and to
reduce regulatory burden:
• remove the requirement for two
copies of an application for exemption
of warning labels for a microwave oven
that are submitted to CDRH and correct
the name of the CDRH office to submit
a document (§ 1030.10(c)(iv)), and
• clarify and remove the requirement
that x-ray assemblers for certified
accessory components submit Reports of
Assembly (Form FDA 2579) to CDRH
(§ 1020.30(d)(2)).
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IV. Legal Authority
FDA is issuing this final rule under
the same authority under which FDA
initially issued these regulations, the
device and general administrative
provisions of the FD&C Act (21 U.S.C.
321, 351, 352, 360, 360e–360j, 360hh–
360ss, 371, 374, and 381). FDA has the
authority under section 534 of the FD&C
Act to amend the performance standard
for diagnostic x-ray systems and their
major components, amend the
performance standard for laser products,
and repeal radiation protection
recommendations and the performance
standard for ultrasonic therapy
products, as provided for in this final
rule.
V. Comments on the Proposed Rule and
FDA’s Responses
We received several sets of comments
on the proposed rule by the closure of
the comment period, each containing
one or more comments on one or more
issues. We received comments from
medical device associations, industry,
medical and healthcare professional
associations, public health advocacy
groups, and individuals. We describe
and respond to the comments in this
section of the document. The topics for
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the comments are grouped based on the
common themes identified below. We
have grouped similar comments
together under the same number so that
FDA’s responses could be addressed by
topic, instead of each comment
addressed independently, and, in some
cases, we have separated different issues
discussed in the same comment and
designated them as distinct comments
for purposes of our responses. The
number assigned to each comment or
comment topic is purely for
organizational purposes and does not
signify the comment’s value or
importance or the order in which
comments were received.
A. General Comments on the Proposed
Rule
(Comment 1) FDA received multiple
comments that express support for the
proposed rule and the proposals to
remove outdated radiation protection
recommendations and adjust the
regulatory records and reporting
requirements based on risk. The
comments urged the Agency to maintain
vigilance and continue to promote the
health and safety of patients and
healthcare practitioners.
(Response 1) FDA appreciates the
public support for the rule. FDA intends
to continue to utilize its regulatory
authorities and collaborations with
other governmental agencies, nongovernmental organizations, and
industry, among others, to promote the
safe and effective use of radiation to best
protect and promote public health.
B. Radiation Safety Recommendations/
Standards Comments
(Comment 2) One comment
referenced multiple publications that
supported FDA’s proposal that the
recommendations in § 1000.50 for use of
gonad shielding were inconsistent with
current scientific evidence and should
be removed.
(Response 2) FDA agrees with the
recommendation and is removing the
recommendations in § 1000.50 in this
final rule.
(Comment 3) One comment raised
concern that by repealing the radiation
protection recommendations, end-users
may have difficulty finding, analyzing,
and applying the appropriate standards
and practices to specific clinical
healthcare situations. The comment
requested that FDA list the specific
regulations that are outdated or
duplicative and provide direction as to
the appropriate current standards or
practice parameters that replace the
repealed regulations.
(Response 3) FDA acknowledges the
concern but does not believe that repeal
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of the recommendations will cause
difficulty in locating and applying
applicable standards and practices. This
final rule identifies the § 1000.50
recommendations that are being
removed. FDA believes these specific
recommendations are outdated and no
longer relied upon by healthcare
providers. Removing the
recommendations eliminates
information that is no longer useful.
FDA identified recent, consensus
recommendations in the proposed rule
(Refs. 1, 2, 6–9). FDA continues to
recommend that medical professionals
also seek continuing education through
professional societies to remain current
with new technologies, standards, and
best practice guidelines.
(Comment 4) Multiple comments
recognized the contributions of external
stakeholders to develop and incorporate
radiation protection into device design,
practitioner training, and best practices
for standards of care. Comments stated
that diagnostic imaging is an important
part of the standard of care, and training
and continuing education are important
so that healthcare professionals know
the rules, regulations, safety procedures,
and best practices to benefit patients
and avoid harm. The comments
requested that FDA support and
reference the most relevant guidelines
for healthcare professionals wherever
feasible.
(Response 4) FDA recognizes the
importance of training and continuing
education for healthcare professionals
and will continue to collaborate with,
and reference the work of, external
organization as appropriate to develop
standards. FDA believes professional
societies should have the resources and
knowledge to provide the most up-todate guidelines for their members. FDA
recognizes the significant and ongoing
contributions that external stakeholders,
such as the American Association of
Physicists in Medicine, the American
College of Radiology, the Health Physics
Society, the Image Gently Alliance, the
International Atomic Energy Agency,
the Medical Imaging Technology
Alliance, the Society of Interventional
Radiology, the World Health
Organization, and many others, have
made to incorporate radiation protection
into device design, practitioner training,
and best practices for standards of care.
For example, in 2003, the National
Council on Radiation Protection and
Measurements (NCRP) updated its
recommendations on radiation
protection in dentistry (Ref. 6). In 2012,
the American Dental Association, in
conjunction with FDA, updated its
selection criteria for dental imaging
with guidelines for the frequency of
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dental radiographs and radiation
exposure recommendations (Ref. 7). In
2014, the Environmental Protection
Agency’s (EPA) Working Group on
Medical Radiation, with active FDA
participation, published a document
entitled ‘‘Federal Guidance Report No.
14. Radiation Protection Guidance for
Diagnostic and Interventional X-Ray
Procedures’’ (Guidance Report No. 3),
which provides comprehensive
recommendations for radiation
protection to medical and dental
facilities (Ref. 1). Because safety
procedures and best practices are
continuously revised and improved,
FDA believes that specifically
referencing existing guidelines in the
regulations is not appropriate because it
may lead to confusion or unintended
consequences as practice guidelines
continue to be updated.
(Comment 5) One comment
acknowledges that professional
organizations play a key role in
developing guidance for safe use of
radiation, but such guidance may not be
comprehensive. The comment
recommended that FDA define the
organizational credentials and processes
to guide the development and format of
radiation use standards.
(Response 5) FDA disagrees with the
recommendation because the EPRC does
not provide for defining and enforcing
criteria by which standards
organizations or professional societies
operate (see sections 532, 534(a)(1), and
537(b) of the FD&C Act). FDA’s
standards program provides FDA with
the opportunity to review and rely on
appropriately developed standards
within the scope of the FD&C Act. FDA
actively participates in the development
of voluntary standards and guidelines
with other organizations. FDA
encourages individuals and professional
societies to join and participate in the
development of safety recommendations
and standards to address the diversity of
clinical, scientific, and other needs that
apply to their profession.
(Comment 6) One comment suggested
that one national set of standards,
regulations and training requirements
for operators is preferable to differences
by state or locality. The comment
included a specific example that the
quality of dental radiography may vary
given the lack of national requirements,
especially with the introduction of new
technologies, such as cone-beam
Computerized Tomography (CT). The
lack of a national standard may result in
different approaches to radiographer
training, with the potential for increased
radiation exposure to patients. The
comment recommended that FDA
designate a specific organization as the
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responsible entity on all aspects of
dental imaging including training of all
dental personnel who perform dental
imaging examinations.
(Response 6) FDA disagrees with the
recommendation. The EPRC does not
provide for defining and enforcing
criteria by which standards
organizations or professional societies
operate, or for designating an
organization(s) to define or enforce such
requirements. FDA notes that such
standards and training are generally
provided for by appropriate
organizations and professions, and FDA
frequently collaborates with these
organizations and professions. FDA
supports the continuation of such efforts
by these entities to educate members on
best practices for safe use of radiation in
their profession. For dental imaging
specifically, FDA, in collaboration with
the Conference of Radiation Control
Program Directors (CRCPD), recently
completed a nationwide survey of the
use of radiation in dental imaging
facilities (Ref. 10). FDA staff
participated in developing a report by
the National Council on Radiation
Protection and Measurements (NCRP)
on radiation protection in dentistry (Ref.
11). FDA has also collaborated with the
American Dental Association on
guidelines for the selection of patients
for dental radiographic examinations
(Ref. 7). FDA hopes the results of these
kinds of collaborations, and other work
from similar organizations, will help
inform FDA and other organizations of
best practices and recommendations for
training and equipment standards.
(Comment 7) One comment
recommended FDA withdraw the rules
and regulations for the lowest risk
radiation emitting electronic products
first. The commenter suggested
removing reporting of assembly for wall
mounted x-ray generators for intraoral
radiography, while maintaining
reporting for handheld portable x-ray
generators for use in dentistry, which
are relatively new and without the same
safety record.
(Response 7) FDA disagrees with the
comment. FDA has taken a risk-based
assessment in amending the regulations.
FDA considers submission to FDA of
any report of assembly for certified
components of diagnostic x-ray
products to no longer be necessary,
while continuing to facilitate the
submission of such reports of assembly,
where applicable, to State agencies and
purchasers. Diagnostic x-ray systems
still need to meet the product-specific
performance standards under part 1020
(21 Code of Federal Regulations (CFR),
part 1020), including the submission of
any reports of assembly of installed
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certified components as applicable.
Diagnostic x-ray systems, including
handheld dental x-ray units, will also
continue to be subject to applicable
medical device regulations (see, e.g., 21
CFR parts 803, 807, 820, 872, and 892).
(Comment 8) Some comments support
the use of international voluntary
consensus standards to help ensure
regulatory requirements are met.
Commenters noted the benefits,
including consistency in regulation,
global harmonization, efficiencies,
minimizing unnecessary costs and
delays in patient access to innovative
new devices and promoting safety, and
consistency with the National
Technology Transfer and Advancement
Act (Pub. L. 104–113), and Office of
Management and Budget’s (OMB)
directive Circular A–119, Federal
Participation in the Development and
Use of Voluntary Consensus Standards
and in Conformity Assessment
Activities (Ref. 12).
(Response 8) FDA agrees with these
comments and will continue to
participate in the development of
international standards and their use for
regulatory purposes as appropriate.
(Comment 9) One comment expressed
interest in FDA providing information
on future technologies and other
measures that may reduce or eliminate
radiation exposure.
(Response 9) FDA recommends that
medical professionals seek continuing
education through their appropriate
professional societies to maintain
knowledge of new technologies and best
practice guidelines. With respect to
medical devices, FDA’s Q-Submission
Program (Ref. 13) offers manufacturers
the opportunity to receive feedback on
their proposed regulatory pathway and
test plans when developing new devices
and technologies that may improve
image quality and patient safety.
C. General Format and Edit Comments
(Comment 10) One comment
recommended reformatting table 1 of
§ 1002.1 for clarity by merging and
shading the category rows.
(Response 10) FDA understands the
concern for readability of the
regulations; however, FDA is limited in
the formatting tools available for display
and printing of regulations in the
Federal Register and the CFR, as such
stylistic issues are determined by the
U.S. Government Publishing Office for
the entire Federal government. The
information will continue to be
displayed in table 1 as formatted and
published in the proposed rule.
(Comment 11) One comment
recommended clarifying in
§§ 1002.20(b) and 1010.4(b) whether
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submission of both electronic and paper
reports and variance requests are
acceptable.
(Response 11) FDA agrees with the
recommendation and is revising the
language in §§ 1002.20(b) and 1010.4(b)
to clarify that ‘‘either’’ electronic or
paper submissions are appropriate.
(Comment 12) One comment
recommended that the regulations allow
for use of the International Organization
for Standardization (ISO) standard date
format (‘‘YYYY–MM–DD’’), which is
required for medical devices in 21 CFR
801.18(a), as an alternative to the EPRC
format specified in § 1010.3(a)(2)(ii).
(Response 12) FDA agrees with the
recommendation and is revising the
regulation to alternatively provide for
use of a manufacturing symbol and date
format that is in accordance with
applicable FDA recognized consensus
standards, such as ISO 7000: Graphical
symbols for use on equipment and IEC
60417: Graphical symbols for use on
equipment (Ref. 14) (see
§ 1010.3(a)(2)(ii) of this final rule).
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D. Records and Reports Comments
(Comment 13) One comment
requested clarification of the document
retention requirements related to initial
(§ 1002.10), supplemental (§ 1002.11),
abbreviated (§ 1002.12), and annual
reports (§ 1002.13). The Agency was
asked to state clearly that manufacturers
will no longer need to generate and
retain these reports.
(Response 13) The proposed rule
modified table 1 (§ 1002.1) to show that
manufacturers of diagnostic x-ray
products would no longer need to
submit initial (§ 1002.10), supplemental
(§§ 1002.11), abbreviated (§ 1002.12),
and annual reports (§ 1002.13). In the
final rule, we are maintaining this
change. As a result, manufacturers of
diagnostic x-ray systems will no longer
need to generate and retain such reports
related to diagnostic x-ray systems. To
clarify, this modification would not
remove these requirements for all
products listed under table 1 (§ 1002.1
of this final rule). Many other reporting
and recordkeeping requirements are
unchanged including, as applicable
based on the requirements in § 1002.1,
the requirements for test and
distribution records specified in
§ 1002.30.
(Comment 14) One comment
requested that FDA clarify if an annual
report would still be required for a
diagnostic x-ray system that falls within
this category due to its display being
classified as a television product
(§ 1020.10). The comment suggested
removing the reporting requirements for
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such displays that are included in
diagnostic x-ray systems.
(Response 14) FDA appreciates the
comment and recognizes there may be
confusion about reporting requirements
for diagnostic x-ray systems that include
television displays. FDA agrees that
reporting should not be required for
medical device manufacturers of
diagnostic x-ray systems that use
modern display technologies (e.g., light
emitting diode and liquid crystal
display) that do not incorporate a
cathode ray tube display. However, FDA
believes that the reporting requirement
should be maintained for displays that
do contain a cathode ray tube, and were
manufactured subsequent to January 15,
1970, because these types of displays
generate ionizing radiation during use.
FDA is therefore amending § 1020.10(a)
to clarify that the television product
performance standard (and thus
reporting requirements) only applies to
televisions/displays that contain a
cathode ray tube. FDA believes EPRC
reporting for such older technologies is
necessary for the public health and
safety to monitor the use of cathode ray
tubes in televisions/displays. Given the
outdated nature of the cathode ray tube
technology, at this time, FDA believes
this type of television display included
in diagnostic x-ray systems is the only
type that would continue to benefit from
the annual reporting requirement.
Therefore, FDA does not believe that
excluding this type of television display
product from the reporting requirements
is appropriate at this time.
(Comment 15) One comment
requested FDA to clarify how the
changes in reporting would impact the
process for manufacturers to receive
accession numbers, which are used for
customs clearance.
(Response 15) Manufacturers of
diagnostic x-ray systems that are no
longer required to submit product
reports, and who therefore will no
longer receive an accession number,
will no longer need to submit an
accession number when importing
products (see § 1002.1, table 1 of this
final rule). The import process for
diagnostic x-ray systems will be the
same as for other medical devices that
do not require submission of product
reports. Manufacturers can refer to
FDA’s website for more information on
the imports process and program (Ref.
15).
(Comment 16) One comment
mentioned the concern that if the
records and reporting requirements for
electronic products and medical devices
are removed or reduced, then end-users
will rely on state requirements, which
may not have changed in many years.
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The comment raised concerns that in
some states, repealing regulations for
records and reporting requirements for
electronic products and medical devices
may be catastrophic if a recall on
ionizing radiation equipment were
issued.
(Response 16) FDA believes
recordkeeping is important in case of
recalls and that compliance with all
applicable performance standards is
important to ensure the protection of the
public health and safety. The
amendments do not change FDA’s
authority or a manufacturer’s
responsibilities if a product is defective
or fails to comply with performance
standards under section 534 of the
FD&C Act. The final rule does not
change any of the manufacturer, dealer,
or distributer recordkeeping
requirements under §§ 1002.1, 1002.30,
1002.40, or 1002.41 that are used to
notify potentially impacted persons.
The final amendments also do not
change the reporting, notification, and
requirements to perform corrective
actions under part 1003 (21 CFR part
1003) for electronic product defects or
failure to comply with a performance
standard. Lastly, the amendments do
not change any of the regulations
applicable to the recall of medical
devices under 21 CFR part 806.
Therefore, FDA disagrees that it would
be catastrophic if a recall on ionizing
radiation equipment were issued
following these amendments.
E. Reports of Assembly, Forms, and
Guidances Comments
(Comment 17) Some comments
supported amending the regulations to
no longer require assemblers who install
certified accessory components of
diagnostic x-ray systems to submit
reports of assembly (Form FDA 2579) to
FDA.
(Response 17) FDA agrees with the
comment. In this rulemaking, FDA is
removing the requirement to submit a
copy of Form FDA 2579 to FDA.
Assemblers will still be required to
submit a copy to the purchaser, and,
where applicable, to state agencies
responsible for radiation protection.
(Comment 18) One comment
requested clarification on whether FDA
will continue to make available Form
FDA 2579 for manufacturers to use for
submitting to states and purchasers. A
comment also suggested that the form be
made available in a PDF fillable format
and that it retain a document control
number field.
(Response 18) FDA agrees with this
request and is revising § 1020.30(d)(1) to
specify that Form FDA 2579 is available
online. FDA intends to make the form
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PDF fillable and retain a field on the
form for a document control number.
However, FDA does not intend to
generate or specify the format of
document control numbers.
(Comment 19) One comment asked if
the Agency will generate and/or require
a unique document control number for
each report of assembly, with a
suggestion that manufacturers could
develop a unique identification format
for the document control numbers.
(Response 19) At this time, FDA will
not generate document control numbers
or define the format that manufacturers
utilize. Manufacturers are welcome to
develop a standardized scheme for the
document control number if they wish.
(Comment 20) One comment
requested FDA to clarify if
manufacturers will need to keep a
record of the report of assembly on file.
(Response 20) Assemblers, including
manufacturers who are assembling
diagnostic x-ray equipment, subject to
the provisions of § 1020.30(d) will still
be required under § 1002.1(c)(4) to
maintain a copy of the report of
assembly for 5 years.
(Comment 21) One comment
requested FDA to specify what reporting
guides, forms, and guidance will be
removed from the FDA website.
(Response 21) The Paperwork
Reduction Act (PRA) section of this
final rule (section IX) identifies what
forms will be removed or amended. The
publication of the final rule coincides
with updates to relevant FDA guidance
documents for consistency with the
amended regulations.
(Comment 22) Several commenters
sought clarity on reporting and
recordkeeping responsibilities
associated with the changes in the
proposed rule, including any need to
document reliance on recognized
consensus standards for diagnostic x-ray
systems. While commenters understood
some reports and forms that would no
longer need to be submitted to FDA,
there was uncertainty regarding certain
requirements to generate and maintain
test records and document compliance
with the standards.
(Response 22) Manufacturers will no
longer need to generate certain specific
reports to submit to FDA. In finalizing
the rule, FDA is withdrawing the
reporting guides for reports that are no
longer required to be submitted.
Manufacturers will still need to
maintain test and distribution records
(§ 1002.30), where applicable. If a
manufacturer chooses to conform to
applicable recognized IEC standards in
lieu of conforming to the performance
standards as described in FDA guidance
(Ref. 16), then manufacturers must
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include in their test records
documentation specific to the scope of
the corresponding standards.
F. Accidental Radiation Occurrences
Comments
(Comment 23) Several comments
supported quarterly submission for
AROs that are not associated with a
death or serious injury. One comment
suggested that the regulations be further
amended so that manufacturers of
medical devices that are also electronic
products only need to comply with the
Medical Device Reporting (MDR)
requirements.
(Response 23) ARO reporting is
critical for FDA to meet its
responsibility to identify and reduce
unnecessary sources of radiation
exposure to the public for medical and
non-medical devices. Medical device
manufacturers are required to report
once they are aware of information that
reasonably suggests the medical device
may have caused or contributed to death
or serious injury or there is a
malfunction that, if it were to recur, is
likely to cause or contribute to a serious
injury or death (part 803 (21 CFR part
803)). Medical devices that also meet
the definition of an electronic product
must also comply with the ARO
reporting requirements in § 1002.20,
which requires manufacturers to report
a single event, or series of events, that
resulted in injurious or potentially
injurious exposure of any person to
electronic product radiation as a result
of a malfunction due to the
manufacturing, testing, or use of an
electronic product. The ARO reporting
program is intended to capture both
serious malfunctions that require
immediate action to prevent future
death or injury (which overlaps with
MDRs) and less-serious events (which
may not overlap with MDRs) where
periodic reporting would help identify
unnecessary radiation exposure that
may be addressed through manufacturer
correction or through revisions to safety
standards. For this reason, FDA believes
ARO reporting requirements should be
maintained even when the product is
subject to part 803 reporting
requirements to ensure the protection of
the public health and safety under the
EPRC program.
(Comment 24) One comment
requested that FDA amend the
regulations to state that instances in
which an exposure made by a
healthcare professional that is deemed
to be clinically necessary is not an ARO
even when it is a repeat scan or image
caused by a system interruption.
(Response 24) The term ‘‘accidental
radiation occurrence’’ under § 1000.3(a)
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includes two essential aspects to such
an event. First, electronic product
radiation must have been emitted. For
ionizing radiation, FDA considers the
use of the linear no-threshold model
(i.e., a threshold below the amount of
ionizing radiation that is not
‘‘potentially injurious’’) (Ref. 17) as a
prudent and practical approach for
radiation protection. Second, the
radiation emission must have been
accidental, by which the Agency means
that the emission was unintended and
unexpected. An intended and expected
radiation emission, such as an
intentional repeat scan or image, does
not meet the criterion of ‘‘accidental’’
and is not an ARO. To improve clarity
on this distinction, FDA is amending
the definition of an ARO (§ 1000.3(a) in
this final rule) to include the word
‘‘accidental’’ within the definition to
more clearly indicate that an ARO is an
accidental event resulting in radiation
exposure. With this clarification, FDA
does not believe it is necessary to
further amend the regulation by
providing specific examples involving
radiation occurrences that are not
considered to be accidental.
(Comment 25) A few comments asked
FDA to clarify how the tracking and
trending analysis relates to the
requirements in § 1002.20(a) and (b) and
what would be expected as part of this
new requirement.
(Response 25) FDA acknowledges
there may be confusion regarding how
the quarterly summary reporting with
tracking and trending analysis relates to
the requirements under § 1002.20(a) and
(b). FDA is therefore amending
§ 1002.20 to clarify that: (1) the
quarterly report must include
information required under
§ 1002.20(b)(1) through (7) for each
occurrence where known to the
manufacturer, (2) that accidental
radiation occurrences may be grouped
to identify the most common
circumstances and potential cause(s),
including but not limited to, design
changes, manufacturing, or user, and (3)
that planned mitigation(s) with an
assessment of effectiveness, or a
justification for why mitigation is not
necessary, must be associated with each
occurrence or grouping of similar
occurrences (see § 1002.20(c)(2)(ii) in
this final rule). Such incidents should
also be evaluated to determine if the
accidental radiation occurrence is the
result of a defect as defined in § 1003.2
of this chapter or fails to comply with
an applicable Federal standard (see
§ 1003.10). Medical device
manufacturers may be able to rely on
information already being generated as
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part of their corrective and preventive
actions (21 CFR 820.100).
(Comment 26) A few comments asked
FDA to clarify if the tracking and
trending analysis applied to both
immediate reports and quarterly reports.
(Response 26) The submission of the
tracking and trending analysis only
applies to quarterly reporting.
G. Laser Comments
(Comment 27) Several comments
stated that the proposed amendments to
§ 1040.10 were confusing and should be
clarified. The comments raised concerns
about creating a circular logic path
between the text proposed in
§ 1040.10(a)(1), which indicates the
standard is not applicable to an
uncertified laser product that is
incorporated into an electronic product
that is then certified by the
manufacturer, and the certification
requirements in § 1010.2(a), which
requires certification when the
performance standard is applicable.
Commenters stated that the term
‘‘uncertified’’ in proposed
§ 1040.10(a)(1), along with other edits,
caused confusion because certain
aspects of the standard appeared to be
required/applicable, while certification
was not required.
Multiple comments recommended
that FDA either: (1) revise or keep the
original language of certain paragraphs
in § 1040.10, with removal or
modifications to specific sections for
clarity or (2) keep the existing language
in § 1040.10(a) and instead modify
§§ 1002.1(c), 1010.2, and 1010.3, which
would have the effect of §§ 1040.10 and
1040.11 still being required even if
certification, identification, and
manufacturer’s reports are not required.
(Response 27) FDA agrees with the
latter recommended approach (#2) to
keep the existing language in § 1040.10,
and instead amend § 1002.1 in table 1
and § 1010.2, consistent with the
amendments in the proposed rule, to
clarify when and under what conditions
reporting would not need to be
duplicated. In those situations, the
manufacturers would be considered
distributors of certified laser products,
and only subject to the applicable
distribution recordkeeping requirements
under §§ 1002.40 and 1002.41 for the
certified products (see § 1002.1, table 1,
fn. 9 in this final rule). Also, we are
revising § 1010.2 to identify the
conditions under which a manufacturer
could incorporate a certified laser
product without the requirement to recertify or re-report the product (see
§ 1010.2(e) of this final rule).
(Comment 28) Some comments raised
concerns that the proposed language in
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§ 1040.10(a)(2) did not clearly require
products to comply with the
performance standards after a certified
laser was incorporated.
(Response 28) The intent of the
modifications in the proposed rule was
to avoid duplicative reporting of
information from manufacturers who
incorporate a certified laser system into
a product. The certified laser system,
and the product into which it is
incorporated, would still be required to
conform with the performance
standards. Products that incorporate a
certified laser product are still required
to comply with the FDA’s performance
standards. To clarify this, we are
revising § 1010.2 to clearly identify
under what conditions a product that
incorporates a certified laser system
would be considered certified, and thus
not need to be re-certified. In this final
rule, all of the following conditions
must be met: (1) the incorporated laser
system is not a laser product intended
for use as a component or replacement
as described in § 1040.10(a)(1) and (2);
(2) the manufacturer of the incorporated
laser system certifies such laser system
and meets the reporting requirements
under § 1002; (3) the product
incorporating the certified laser system
is not independently subject to
additional reporting or performance
standards requirements; (4) the
incorporated laser system is not
modified as defined in § 1040.10(i), and
all performance features that apply to
the incorporated laser system under
§ 1040.10(f) are available on the product
incorporating the certified laser system;
(5) all labeling requirements that apply
to the incorporated laser system under
§§ 1010.2, 1010.3, 1040.10(g), and
1040.11(a)(3) are visible on the outside
of the product incorporating the
certified laser system, with the
exception that the certification or
identification labels need not be visible
on the outside of products incorporating
a certified Class I laser; (6) the
incorporated laser system is installed in
the product in accordance with the
instructions provided by the
manufacturer of the incorporated laser
system, including instructions for
placing additional externally facing
labels found in subsection (v), and
meeting the other conditions in the
subsections; (7) the manufacturer of the
product that incorporates the laser
system provides the end user with
information required under
§ 1040.10(h)(1) as provided to them by
the manufacturer of the incorporated
laser system; and (8) the labeling
requirements under part 1010 and
§ 1040.10(g) for the incorporated laser
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system would be met in any service
configuration of the product
incorporating the laser system or when
the incorporated laser system is
removed from the product into which it
has been incorporated, and
reproductions of such labels are found
in the user information. Manufacturers
of products that do not meet these
conditions would need to certify and
report the product that incorporates the
certified laser system based on the class
of the laser product as described in
§ 1002.1.
(Comment 29) One comment raised
concerns regarding the criteria for the
incorporated laser system to be installed
in accordance with the instructions
provided by the manufacturer of the
incorporated laser system. The comment
stated that it would be difficult for the
manufacturer of the incorporated laser
system to foresee all potential
installation options by other
manufacturers.
(Response 29) FDA does not expect
the manufacturer of an incorporated
laser system to foresee all potential
installation options. FDA expects that a
manufacturer planning to market a laser
product specifically to be certified and
incorporated into other systems would
identify and specify any installation
options and requirements, while taking
into consideration how reasonable
variations in the installation
instructions should be provided to
customers to ensure the conditions in
§ 1010.2(e) are met. However,
ultimately, the manufacturer of the
incorporated laser system is responsible
for ensuring their finished product is in
compliance with all applicable
regulatory requirements when certified
and marketed. The manufacturer of the
product incorporating the laser system
is responsible for complying with the
conditions in § 1010.2(e). Otherwise,
those manufacturers would need to
complete the certification, reporting,
and other applicable laser product
requirements under §§ 1002 and
1040.10. For example, if the installation
instructions would result in the laser
product not meeting the conditions
under § 1010.2(e) (e.g., instructions that
would result in a required safety
interlock being unavailable), then the
product incorporating the certified laser
would not be considered to have met
the certification requirements because
all conditions in § 1010.2(e) must be
met.
(Comment 30) FDA received
comments expressing concern with the
incorporation into regulation the
policies described in FDA’s Laser Notice
42, including expansion of those
policies into regulation for higher
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powered laser products without the
requirements that the products
incorporating higher power lasers
comply with the performance standards.
A commenter questioned whether the
reporting requirements and performance
standard would be applicable to a
product that incorporated a certified
Class I laser along with an uncertified
Class IV laser, and if the labeling or
safety features of the final product
would need to meet the Class IV
performance standards. Similar
comments recommended that FDA
revise and extend policies of Laser
Notice 42 for clarity with additional
requirements to ensure safety of higher
class products.
(Response 30) As noted in Response
28, this final rule is revising § 1010.2 to
identify under what conditions a
product that incorporates a certified
laser system would be considered to
have met the certification requirements.
There are several conditions, all of
which must be met, including that the
product incorporating the certified laser
system must not be independently
subject to additional reporting
requirements or performance standards
(see § 1010.2(e)(iii) in this final rule).
FDA added this clarification to the
revisions under § 1010.2(e) of this final
rule to ensure higher class products will
continue to be subject to any applicable
certification requirements, despite the
incorporated laser system having met
the certification requirements. For
example, a Class IV laser product that
incorporates a certified Class I laser
does not meet the conditions in
§ 1010.2(e)(iii), as additional
certification and reporting requirements
associated with the Class IV laser still
apply. In addition, the incorporated
laser system must not be modified, as
defined in § 1040.10(i), and all
performance features that apply to the
incorporated laser system under
§ 1040.10(f) must be available on the
product incorporating the certified laser
system (see § 1010.2(e)(iv) in this final
rule). All labeling requirements that
apply to the incorporated laser system
under § 1040.10(g) must be visible on
the outside of the product incorporating
the certified laser system, with the
exception that the certification or
identification labels need not be visible
on the outside of products that
incorporate a certified Class I laser (see
§ 1010.2(e)(v) in this final rule). The
incorporated laser system must be
installed in accordance with the
instructions provided by the
manufacturer of the incorporated laser
system, including ensuring any required
safety features or labeling are available
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(see § 1010.2(e)(vi) in this final rule).
The manufacturer of the product
incorporating the laser system must also
provide the end user with laser safety
information as provided to them by the
manufacturer of the incorporated laser
system (see § 1010.2(e)(vii) in this final
rule). In addition, the labeling
requirements in part 1010 and
§ 1040.10(g) for the incorporated laser
system must be met in any service
configuration of the product that
incorporates the laser system, including
when the incorporated laser system is
removed from the product into which it
has been incorporated, and
reproductions of such labels must be
included in the user information (see
§ 1010.2(e)(viii) in this final rule).
(Comment 31) One comment
recommended limiting the amendments
only to the lowest class of laser
products; or a subset of classes with
additional clarification to address the
visibility of the warning logo type and
aperture label; or all classes with
clarifications about the difference
between ‘‘attaching’’ versus ‘‘assembling
in, embedding in, or otherwise
incorporating’’ a laser or laser system.
(Response 31) FDA believes that the
revisions to §§ 1002.1 and 1010.2(e) that
are being made in this final rule make
it sufficiently clear that the
manufacturer of the product
incorporating the certified laser must
not make modifications that would alter
the availability of safety information or
compliance with the standard if they
wish to maintain the certification. FDA
has added clarification to the revisions
under § 1010.2(e)(v) and (vi) of this final
rule to ensure that visibility of certain
labeling requirements that apply to the
incorporated laser system continue to be
maintained. Any modifications that
would modify the class of laser,
compliance with the performance
standard, visibility of required labeling,
or accessibility to required safety
information would not meet the
conditions of § 1010.2(e) and the
product would no longer be considered
certified—meaning the manufacturer of
the product incorporating the laser
would need to complete the applicable
certification and reporting requirements
(see also Response 29).
VI. Effective Date
This rule is effective 30 days after the
date of publication in the Federal
Register.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the
final rule under Executive Order (E.O.)
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Fmt 4700
Sfmt 4700
12866, E.O. 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). EOs 12866 and
13563 direct us to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). We believe that
this final rule is not a significant
regulatory action as defined by E.O.
12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities. This
rule will reduce regulations that are
outdated and otherwise clarify existing
requirements. Because this final rule
does not impose any additional
regulatory burdens, we certify that this
final rule will not have a significant
economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before issuing ‘‘any
rule that includes any Federal mandate
that may result in the expenditure by
State, local, and tribal governments, in
the aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any one year.’’
The current threshold after adjustment
for inflation is $165 million, using the
most current (2021) Implicit Price
Deflator for the Gross Domestic Product.
This final rule will not result in an
expenditure in any year that meets or
exceeds this amount.
B. Summary of Costs and Benefits
We estimate the benefits of this rule
in terms of cost savings. We derive the
cost savings to industry from the
reduction in labor associated with the
reporting, recordkeeping, performance
standards, and third-party disclosure
requirements. Similarly, cost savings to
FDA result from the reduction in labor
hours required to review reports. The
total present-value cost savings over a
20-year time period are $69.71 million
at a 7 percent discount rate and $97.89
million at a 3 percent discount rate.
Annualized total cost savings are $6.58
million. We estimate the costs to read
the rule for all reporting respondents.
The present value costs are $1.60
million, and the annualized costs
calculated over a 20-year time period
are $0.14 million at a 7 percent discount
rate and $0.10 million at a 3 percent
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
discount rate. A summary of the
quantified cost savings and costs of the
rule are presented in Table 1.
TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
Units
Primary
estimate
Low estimate
$6.58
6.58
........................
$6.58
6.58
........................
Qualitative .............................
Costs:
Annualized Monetized
$millions/year.
Annualized Quantified ..........
........................
Qualitative .............................
Transfers:
Federal Annualized Monetized $millions/year.
Category
Benefits:
Annualized Monetized
$millions/year.
Annualized Quantified ..........
High estimate
Year dollars
Discount rate
(percent)
Period
covered
$6.58
6.58
........................
2021
2021
........................
20
20
........................
........................
........................
........................
7
3
7
3
........................
0.14
0.10
........................
0.14
0.10
........................
0.14
0.10
........................
2021
2021
........................
........................
........................
........................
........................
........................
........................
........................
........................
From/To ................................
From:
Other Annualized Monetized
$millions/year.
........................
From/To ................................
From:
7
3
7
3
........................
Notes
........................
20
20
........................
........................
7
3
........................
7
3
........................
To:
........................
........................
........................
To:
Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
C. Summary of Regulatory Flexibility
Analysis
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because the rule does not
impose any additional regulatory
burdens, we certify that the final rule
will not have a significant economic
impact on a substantial number of small
entities. This analysis, as well as other
sections in this document and the
Preamble of the final rule, serves as the
Final Regulatory Flexibility Analysis, as
required under the Regulatory
Flexibility Act. The full preliminary
analysis of economic impacts is
available in the docket for this final rule
(Ref. 18) and at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
VIII. Analysis of Environmental Impact
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The Agency has determined under 21
CFR 25.30(h) and (i) and 25.34(c) that
this action is of a type that does not
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individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
IX. Paperwork Reduction Act of 1995
This final rule contains information
collection provisions that are subject to
review by the OMB under the PRA (44
U.S.C. 3501–3521). The title,
description, and respondent description
of the information collection provisions
are shown in the following paragraphs
with an estimate of the annual
reporting, recordkeeping, and thirdparty disclosure burden. Included in the
estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information.
Title: Electronic Products; OMB
Control No. 0910–0025—Revision
Description: FDA is amending its
regulations for requirements for certain
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reporting and records of electronic
products by removing specific reporting,
as well as repealing outdated
recommendations for radiation
protection and performance standards,
and removing submission requirements
for copies of certain applications and
forms to alleviate regulatory burden to
both FDA and industry.
The records and reporting
requirements for electronic products
and medical devices include various
reports and records depending upon the
specific type of electronic product. FDA
has determined upon review of the
records and reporting requirements that
some of the requirements are
unnecessary or may be duplicative of
other reporting requirements by FDA
and State regulators.
Description of Respondents: The
respondents to this information
collection are electronic product
manufacturers, importers, and
assemblers of electronic products from
private sector, for-profit businesses.
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity; 21 CFR section
Product reports—1002.10(a)–
(k) 3.
Supplemental reports—
1002.11(a)–(b) 3.
Abbreviated reports—1002.12 3
Annual reports—1002.13(a)–
(b) 3.
Accidental radiation occurrence reports—1002.20 3.
Exemption requests—
1002.50(a) and 1002.51 4.
Product and sample information—1005.10 4.
Identification information and
compliance status—
1005.25 4.
Alternate means of certification—1010.2(d) 4.
Variance—1010.4(b) 4 .............
Exemption from performance
standards—1010.5(c) and
(d) 4.
Alternate test procedures—
1010.13 4.
Microwave oven exemption
from warning labels—
1030.10(c)(6)(iv) 4.
Laser products registration—
1040.10(a)(3)(i) 4.
Total .................................
Number of
responses per
respondent
Number of
respondents
FDA form
Average
burden per
response
Total annual
responses
Total
hours 2
3639—Cabinet x-ray ...............
3632—Laser ...........................
3640—Laser light show ..........
3630—Sunlamp ......................
3659—TV ................................
3660—Microwave oven ..........
3801—UV lamps .....................
.................................................
1,149
2.2
2,529
24 ....................
60,685
440
2.5
1,100
550
3629—General abbreviated
report.
3646—Mercury Vapor Lamp
Products Radiation Safety
Report.
3663—Microwave products
(non-oven).
3628—General ........................
3634—TV ................................
3641—Cabinet x-ray ...............
3643—Microwave oven ..........
3636—Laser ...........................
3631—Sunlamp ......................
3649—ARO .............................
54
1.8
97
0.5 (30 minutes).
5 ......................
485
1,410
1.3
1,833
18 ....................
32,994
75
4
300
2 ......................
600
3642—General correspondence.
2767—Sample product ...........
4
1.3
5
1 ......................
5
5
1
5
0.1 (6 minutes)
1
2877—Imports declaration ......
12,620
2.5
31,550
.................................................
1
2
2
5 ......................
10
3633—General variance request.
3147—Laser show variance
request.
3635—Laser show notification
.................................................
350
1.1
385
1.2 ...................
462
1
1
1
22 ....................
22
.................................................
1
1
1
10 ....................
10
.................................................
1
1
1
1 ......................
1
70
2.9
203
3 ......................
609
........................
........................
........................
.........................
102,744
3637—Original equipment
manufacturer (OEM) report.
.................................................
0.2 (12 minutes).
6,310
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
have requested revision of this information collection.
4 The burden estimate for this information collection is currently approved and included for the convenience of the reader. We have not requested revision of this line item at this time.
2 Total
3 We
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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Activity; 21 CFR section
Manufacturer test and distribution records—
1002.30 and 1002.31(a) 3.
Dealer/distributor records—1002.40 and
1002.41 3.
Information on diagnostic x-ray systems—
1020.30(g) 4.
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Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours 2
1,409
1,650
2,324,850
0.12 (7 minutes) ...........
278,982
2,909
50
145,450
0.05 (3 minutes) ...........
7,273
50
1
50
0.5 (30 minutes) ...........
25
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
3649
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
Activity; 21 CFR section
Laser products distribution records—
1040.10(a)(3)(ii) 4.
Total .............................................................
Average
burden per
recordkeeping
Total annual
records
Total
hours 2
70
1
70
1 ...................................
70
..........................
........................
........................
......................................
286,350
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
have requested revision of this information collection.
4 The burden estimate for this information collection is currently approved and included for the convenience of the reader. We have not requested revision of this line item at this time.
2 Total
3 We
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Activity; 21 CFR section
Technical and safety information for users—1002.3 3
Dealer/distributor records—1002.40 and 1002.41 3 ....
Television receiver critical component warning—
1020.10(c)(4) 3 ..........................................................
Cold cathode tubes—1020.20(c)(4) 3 ..........................
Report of assembly of diagnostic x-ray components—
1020.30(d), (d)(1)–(2) (Form FDA 2579—Assembler
report) 4 .....................................................................
Information on diagnostic x-ray systems—
1020.30(g) 3 ..............................................................
Statement of maximum line current of x-ray systems—1020.30(g)(2) 3 ..............................................
Diagnostic x-ray system safety and technical information—1020.30(h)(1)–(4) 3 ..........................................
Fluoroscopic x-ray system safety and technical information—1020.30(h)(5)–(6) and 1020.32(a)(1), (g),
and (j)(4) 3 .................................................................
CT equipment—1020.33(c)–(d), (g)(4), and (j) 3 .........
Cabinet x-ray systems information—1020.40(c)(9)(i)–
(ii) 3 ...........................................................................
Microwave oven radiation safety instructions—
1030.10(c)(4) 3 ..........................................................
Microwave oven safety information and instructions—
1030.10(c)(5)(i)–(iv) 3 ................................................
Microwave oven warning labels—1030.10(c)(6)(iii) 3 ..
Laser products information—1040.10(h)(1)(i)–(vi) 4 ....
Laser product service information—1040.10(h)(2)(i)–
(ii) 4 ...........................................................................
Medical laser product instructions—1040.11(a)(2) 3 ....
Sunlamp products instructions—1040.20 3 ..................
Mercury vapor lamp labeling—1040.30(c)(1)(ii) 3 ........
Mercury vapor lamp permanently affixed labels—
1040.30(c)(2) 3 ..........................................................
Total ......................................................................
Average
burden per
disclosure
Total annual
disclosures
Total
hours 2
1
30
1
3
1
90
12
1
12
90
1
1
1
1
1
1
1
1
1
1
1,230
34
41,820
0.3 (18 minutes)
12,546
6
1
6
55
330
6
1
6
10
60
6
1
6
200
1,200
5
5
1
1
5
5
25
150
125
750
6
1
6
40
240
1
1
1
20
20
1
1
2
1
1
1
1
1
2
20
1
20
20
1
40
2
2
1
1
1
1
1
1
2
2
1
1
20
10
10
1
40
20
10
1
1
1
1
1
1
..........................
........................
........................
..............................
15,508
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
burden estimate for this information collection is currently approved and included for the convenience of the reader. We have not requested revision of this line item at this time.
4 We have requested revision of this information collection.
2 Total
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3 The
The estimates were generated from
discussions with subject matter experts
at FDA.
FDA is revising the applicability of
the recordkeeping and reporting
requirements for some products
(§ 1002.1). We revised the burden
estimates for product reports,
supplemental reports, abbreviated
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reports, annual reports, manufacturer
test and distribution records, and dealer
and distributor records by reducing the
number of respondents/recordkeepers to
reflect the revised applicability of the
recordkeeping and reporting
requirements. We also revised Form
FDA 3646 ‘‘Mercury Vapor Lamp
Products Radiation Safety Report’’ (now
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Fmt 4700
Sfmt 4700
listed under Abbreviated Reports
consistent with the revision of § 1002.1)
and removed the following forms:
• Form FDA 3626, ‘‘A Guide for the
Submission of Initial Reports on
Diagnostic X-Ray Systems and Their
Major Components’’
• Form FDA 3627, ‘‘Diagnostic X-Ray
CT Products Radiation Safety Report’’
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
• Form FDA 3638, ‘‘Guide for Filing
Annual Reports for X-Ray
Components and Systems,’’
• Form FDA 3644, ‘‘Guide for Preparing
Product Reports for Ultrasonic
Therapy Products’’
• Form FDA 3645, ‘‘Guidance for
Preparing Annual Reports for
Ultrasonic Therapy Products,’’
• Form FDA 3647, ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Mercury Vapor Lamps’’
• Form FDA 3661, ‘‘Guide for the
Submission of an Abbreviated Report
on X-ray Tables, Cradles, Film
Changers or Cassette Holders
Intended for Diagnostic Use’’
• Form FDA 3662, ‘‘Guide for
Submission of an Abbreviated
Radiation Safety Reports on
Cephalometric Devices Intended for
Diagnostic Use’’
The amended applicability of the
recordkeeping requirements for dealer
and distributor records (see §§ 1002.40
and 1002.41) results in a small decrease
in the number of recordkeepers.
FDA is eliminating requirements for
manufacturers to report model numbers
of new models of a model family that do
not involve changes in radiation
emission or requirements of a
performance standard in quarterly
updates to their annual reporting
(§ 1002.13(c)). We have removed the
burden estimate associated with
§ 1002.13(c). Generally, other
subsections require specified product
manufacturers to submit annual reports
to FDA which summarize certain
manufacturing records (§ 1002.13(a) and
(b)). FDA is not amending these annual
report requirements.
FDA is amending the timing for
submission of reporting requirements
for AROs that are not associated with a
death or serious injury (§ 1002.20). The
amendment will allow manufacturers of
a radiation emitting electronic product
to submit quarterly summary reports of
AROs that are not associated with a
death or serious injury and not required
to be reported under the medical device
reporting regulations (§ 1002.20; part
803). FDA believes that amending the
regulations to allow summary reporting
for AROs for electronic products
extends the approach of eliminating or
reducing duplicative reporting
requirements beyond the medical device
arena and promotes harmonization
between this reporting and the new
voluntary malfunction summary
reporting for medical devices (see part
803; ‘‘Medical Devices and Device-Led
Combination Products; Voluntary
Malfunction Summary Reporting
Program for Manufacturers’’ (83 FR
40973, August 17, 2018)).
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FDA is also amending the
applications for variances process
(§ 1010.4(b)) to no longer require a
manufacturer to submit two additional
copies with the original documents.
While this amendment would not
generate any substantive change to the
information collection, respondents may
realize a small monetary savings from
the usual and customary administrative
expenses associated with the
preparation of the copies.
FDA is amending the reports of
assembly requirements for major
components of diagnostic x-ray systems
to no longer require assemblers who
install certified components to submit a
report of assemblies, Form FDA 2579, to
CDRH (§ 1020.30(d)(1)). FDA is also
withdrawing the language that requires
submission to ‘‘the Director’’ in this
subsection, but will still publish a PDF
form online for assemblers to download,
complete, and provide to applicable
States and purchasers as required. We
have moved the corresponding
information collection burden estimate
from reporting to third-party disclosure
burden and revised Form FDA 2579.
FDA is amending the reporting
requirements for manufacturers that
incorporate a certified laser product to
reduce reporting that is considered
duplicative under certain conditions.
Manufacturers that incorporate a
certified laser system meeting the
conditions of § 1010.2(e) are considered
distributors of the certified laser and
only subject to the applicable
distribution recordkeeping requirements
under §§ 1002.40 and 1002.41 for the
certified products. Accordingly, we
have reduced the number of
respondents for ‘‘Laser products
information—1040.10(h)(1)(i)–(vi)’’ and
‘‘Laser product service information—
1040.11(h)(2)(i)–(ii).’’
FDA is repealing the performance
standards for ultrasonic therapy
products (§ 1050.10). We have therefore
removed the burden estimate associated
with § 1050.10.
We received several comments related
to the proposed rule. Descriptions of the
comments and our responses are
provided in Section V of this document,
Comments on the Proposed Rule and
FDA Response. Comments and
responses related to the provisions that
underlie the information collection are
described in the following sections:
section V.B, regarding general
comments; section V.E, regarding
records and reports; section V.F,
regarding reports of assembly, forms and
guidances; section V.G, regarding
accidental radiation occurrences; and
section V.H, regarding laser comments.
We have not made changes to the
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estimated burden as a result of the
comments.
The information collection provisions
in this final rule have been submitted to
OMB for review as required by section
3507(d) of the PRA.
Before the effective date of this final
rule, FDA will publish a notice in the
Federal Register announcing OMB’s
decision to approve, modify, or
disapprove the information collection
provisions in this final rule. An Agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number.
X. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13132. We have determined that
this rule does not contain policies that
have substantial direct effects on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the E.O. and,
consequently, a federalism summary
impact statement is not required.
We note that the current performance
standards at § 1040.10 issued under
section 534 of the FD&C Act preempt
the States from establishing or
continuing in effect any standard that is
not identical to the Federal standard
pursuant to section 542 of the FD&C
Act. Those standards were issued before
the E.O. We believe this preemption is
consistent with section 4(a) of the E.O.
which requires agencies to ‘‘construe
. . . a Federal statute to preempt State
law only where the statute contains an
express preemption provision or there is
some other clear evidence that the
Congress intended preemption of State
law, or where the exercise of State
authority conflicts with the exercise of
Federal authority under the Federal
statute.’’ Federal law includes an
express preemption provision at section
542 of the FD&C Act that preempts the
States from establishing, or continuing
in effect, any standard with respect to
an electronic product which is
applicable to the same aspect of product
performance as a Federal standard
prescribed pursuant to section 534 of
the FD&C Act and which is not identical
to the Federal standard. (See Medtronic,
Inc. v. Lohr, 518 U.S. 470 (1996); Riegel
v. Medtronic, Inc., 552 U.S. 312 (2008)).
Section 542 of the FD&C Act does allow
States to impose a more restrictive
standard regarding emissions of
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
radiation from electronic products
under certain circumstances.
This final rule does not impose any
new performance standard
requirements. This rule prescribes a
reduction in Federal standards (through
repeal of § 1050.10) pursuant to section
534 of the FD&C Act. This rule removes
or excludes applicability of certain
Federal standards, which no longer
preempt any State issued performance
standards to that same extent.
XI. Consultation and Coordination With
Indian Tribal Governments
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13175. We have determined that
the rule does not contain policies that
would have a substantial direct effect on
one or more Indian tribes, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
Executive Order and, consequently, a
tribal summary impact statement is not
required.
XII. References
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The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. They
also can be purchased as a pdf or as
hard copy (or both together, at a
discounted price) from NCRP
(www.ncrponline.org). FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
*1. EPA, Interagency Working Group on
Medical Radiation, Federal Guidance
Report No. 14. ‘‘Radiation Protection
Guidance for Diagnostic and
Interventional X-Ray Procedures,’’ 2014,
available at https://www.epa.gov/sites/
production/files/2015-05/documents/
fgr14-2014.pdf.
2. NCRP, ‘‘Radiation Dose Management for
Fluoroscopically-Guided Interventional
Procedures,’’ Report No. 168, 2010,
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15:54 Jan 19, 2023
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available at https://ncrponline.org/
publications/reports/ncrp-report-168/.
*3. FDA, CDRH Health, ‘‘Initiative to Reduce
Unnecessary Radiation Exposure from
Medical Imaging’’ (2010), available at
https://www.fda.gov/radiation-emittingproducts/initiative-reduce-unnecessaryradiation-exposure-medical-imaging/
white-paper-initiative-reduceunnecessary-radiation-exposuremedical-imaging#:∼:text=practicing%20
medical%20community.-,Initiative%20
to%20Reduce%20Unnecessary%20
Radiation%20Exposure%20
from%20Medical%20
Imaging,CT%2C%20
fluoroscopy%2C%20
and%20nuclear%20medicine.
*4. FDA, ‘‘Medical X-ray Imaging,’’ available
at https://www.fda.gov/RadiationEmittingProducts/RadiationEmitting
ProductsandProcedures/
MedicalImaging/MedicalX-Rays/
default.htm.
*5. 2016 TEPRSSC Meeting, October 25–26,
2016, available at https://www.fda.gov/
AdvisoryCommittees/CommitteesMeeting
Materials/Radiation-EmittingProducts/
TechnicalElectronicProductRadiation
SafetyStandardsCommittee/
ucm526004.htm.
6. NCRP, ‘‘Radiation Protection in Dentistry,’’
Report No. 145, 2003, available at
https://ncrponline.org/publications/
reports/ncrp-reports-145/.
*7. American Dental Association and FDA,
‘‘Dental Radiographic Examinations:
Recommendations for Patient Selection
and Limiting Radiation Exposure,’’
revised: 2012, available at https://
www.fda.gov/media/84818/download.
*8. The American College of Radiology
publishes and regularly updates Practice
Parameters, Technical Standards, and
Appropriateness Criteria®, available at
https://www.acr.org/Quality-Safety/
Appropriateness-Criteria.
*9. ICRP, ‘‘The 2007 Recommendations of the
International Commission on
Radiological Protection. ICRP
publication 103.’’ Annals of the ICRP.
2007;37(2–4):1–332, available at https://
www.icrp.org/publication.asp?id=
ICRP%20Publication%20103.
10. Nationwide Evaluation of X-Ray Trends
(NEXT), ‘‘Tabulation and Graphical
Summary of the 2014–2015 Dental
Survey.’’ February 2019. CRCPD
Publication-E–16–2, available at https://
cdn.ymaws.com/www.crcpd.org/
resource/collection/81C6DB13-25B14118-8600-9615624818AA/E-19-2_20142015_Dental_NEXT_Summary_
Report.pdf.
11. NCRP, ‘‘Radiation Protection in Dentistry
and Oral and Maxillofacial Imaging.
Report No. 177,’’ 2019, available at
https://ncrponline.org/shop/reports/
report-no-177/.
*12. OMB directive Circular A–119, ‘‘Federal
Participation in the Development and
Use of Voluntary Consensus Standards
and in Conformity Assessment
Activities,’’ available at https://
www.federalregister.gov/documents/
2016/01/27/2016-01606/revision-of-omb-
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
3651
circular-no-a-119-federal-participationin-the-development-and-use-ofvoluntary.
*13. FDA, ‘‘Requests for Feedback and
Meetings for Medical Device
Submissions: The Q-Submission
Program,’’ May 7, 2019, available at
https://www.fda.gov/media/114034/
download.
14. IEC 60417:2002 DB, ‘‘Graphical Symbols
for Use on Equipment,’’ available at
https://webstore.iec.ch/publication/2098.
*15. FDA, Import Program, available at
https://www.fda.gov/industry/importprogram-food-and-drug-administrationfda.
*16. FDA, ‘‘Medical X-Ray Imaging Devices
Conformance with IEC Standards,’’ May
8, 2019, available at https://
www.fda.gov/media/99466/download.
17. NCRP, ‘‘Management of Exposure to
Ionizing Radiation: Radiation Protection
Guidance for the United States. Report
No. 180,’’ 2018, available at https://
ncrponline.org/shop/reports/report-no180-management-of-exposure-toionizing-radiation-radiation-protectionguidance-for-the-united-states-20182018/.
*18. Economic Analysis of Impacts:
Radiological Health Regulations;
Amendments to Records and Reports for
Radiation Emitting Electronic Products;
Amendments to Performance Standards
for Diagnostic X-ray, Laser and
Ultrasonic Products, available at https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
List of Subjects
21 CFR Parts 1000 and 1002
Electronic products, Radiation
protection, Reporting and recordkeeping
requirements, X-rays.
21 CFR Part 1010
Administrative practice and
procedure, Electronic products, Exports,
Radiation protection.
21 CFR Part 1020
Electronic products, Medical devices,
Radiation protection, Reporting and
recordkeeping requirements, Television,
X-rays.
21 CFR Part 1030
Electronic products, Microwave
ovens, Radiation protection.
21 CFR Part 1050
Electronic products, Medical devices,
Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 1000,
1002, 1010, 1020, 1030, and 1050 are
amended as follows:
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
PART 1000—GENERAL
1. The authority citation for part 1000
continues to read as follows:
■
Authority: 21 U.S.C. 360hh–360ss.
2. Amend § 1000.3 by revising
paragraph (a) and removing paragraph
(s) and redesignating paragraphs (t) and
(u) as paragraphs (s) and (t).
The revision reads as follows:
■
§ 1000.3
*
Definitions.
*
*
*
(a) Accidental radiation occurrence
means a single accidental event or series
of accidental events that has/have
resulted in injurious or potentially
injurious exposure of any person to
electronic product radiation as a result
of the manufacturing, testing, or use of
an electronic product.
*
*
*
*
*
PART 1002—RECORDS AND
REPORTS
4. The authority citation for part 1002
continues to read as follows:
■
Authority: 21 U.S.C. 352, 360, 360i, 360j,
360hh–360ss, 371, 374.
5. Amend § 1002.1 by revising table 1
to read as follows:
*
*
*
*
*
■
Subpart C—[Removed]
3. Remove subpart C, consisting of
§§ 1000.50, 1000.55, and 1000.60.
■
*
TABLE 1 TO § 1002.1—RECORD AND REPORTING REQUIREMENTS BY PRODUCT
Manufacturer
lotter on DSK11XQN23PROD with RULES1
Products
DIAGNOSTIC X-RAY 3 (1020.30, 1020.31, 1020.32,
1020.33):
Computed tomography ......................................................
X-ray system 4 ....................................................................
Tube housing assembly .....................................................
X-ray control .......................................................................
X-ray high voltage generator .............................................
X-ray table or cradle ..........................................................
X-ray film changer ..............................................................
Vertical cassette holders mounted in a fixed location and
cassette holders with front panels .................................
Beam-limiting devices ........................................................
Spot-film devices and image intensifiers manufactured
after April 26, 1977 .........................................................
Cephalometric devices manufactured after February 25,
1978 ................................................................................
Image receptor support devices for mammographic X-ray
systems manufactured after September 5, 1978 ...........
CABINET X RAY (1020.40):
Baggage inspection ...........................................................
Other ..................................................................................
PRODUCTS INTENDED TO PRODUCE PARTICULATE
RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC
OR CABINET X-RAY:
Medical ...............................................................................
Analytical ............................................................................
Industrial .............................................................................
TELEVISION PRODUCTS (1020.10):
<0.1 milliroentgen per hour (mR/hr) IRLC 5 .......................
≥0.1mR/hr IRLC 5 ...............................................................
MICROWAVE/RF:
MW ovens (1030.10) .........................................................
MW diathermy ....................................................................
MW heating, drying, security systems ...............................
RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2–500 megahertz) ..................
OPTICAL:
Laser products (1040.10, 1040.11) ...................................
Class I lasers and products containing such lasers 7 9 .....
Class I laser products containing class IIa, II, IIIa, lasers 7 9 ............................................................................
Class IIa, II, IIIa lasers and products other than class I
products containing such lasers 7 9 ................................
Class IIIb and IV lasers and products containing such lasers 7 ...............................................................................
SUNLAMP PRODUCTS (1040.20):
Lamps only .........................................................................
Sunlamp products ..............................................................
Mercury vapor lamps (1040.30) .........................................
R lamps and T lamps ........................................................
Dealer &
distributor
Product
reports
1002.10
Supplemental
reports
1002.11
Abbreviated
reports
1002.12
Annual
reports
1002.13
Test
records
1002.30(a) 1
Distribution
records
1002.30(b) 2
Distribution
records
1002.40 and
1002.41
................
................
................
................
................
................
................
................
................
................
................
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................
................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
........................
X
X
X
........................
................
................
................
................
........................
........................
........................
........................
X
X
X
X
X
X
................
................
........................
........................
X
X
X
................
................
........................
........................
X
X
........................
................
................
........................
........................
X
X
X
X
X
X
X
........................
........................
X
X
X
X
X
X
X
........................
................
................
................
................
................
................
........................
X
X
........................
X
X
X
X
X
X
X
X
........................
........................
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................
X8
................
................
X8
........................
X6
X
...................
X
....................
X
........................
........................
X8
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................
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................
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X
X
X
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X
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X
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................
X
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................
X8
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X
...................
X
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X
................
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X
X
X
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X
................
........................
X
X
X
X
X
X
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X
X
X
X
X
X
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................
................
X
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X
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X
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...................
X
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...................
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X
....................
....................
........................
X
........................
........................
1 However,
authority to inspect all appropriate documents supporting the adequacy of a manufacturer’s compliance testing program is retained.
requirement includes §§ 1002.31 and 1002.42, if applicable.
3 Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see § 1020.30(d)(1)–(3) of this chapter.
4 Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 1020.30(c) of this chapter.
5 Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (§ 1020.10(c)(3)(iii)) of this chapter.
6 Annual report is for production status information only.
7 Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
2 The
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
3653
8 Manufacturers are exempt from product reports (§ 1002.10) and abbreviated reports (§ 1002.12), except the first product or abbreviated report for each category
of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance, service, or failure (e.g., Class I optical
disc products, laser printers).
9 Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified laser and only subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products.
§ 1002.13
[Amended]
6. Amend § 1002.13 by removing
paragraph (c).
■ 7. Revise § 1002.20 to read as follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 1002.20 Reporting of accidental radiation
occurrences.
(a) Manufacturers of electronic
products shall, where reasonable
grounds for suspecting that such an
incident has occurred, report to the
Director, Center for Devices and
Radiological Health, all accidental
radiation occurrences reported to or
otherwise known to the manufacturer
and arising from the manufacturing,
testing, or use of any product
introduced or intended to be introduced
into commerce by such manufacturer.
Reasonable grounds include, but are not
necessarily limited to, professional,
scientific, or medical facts or opinions
documented or otherwise, that conclude
or lead to the conclusion that such an
incident has occurred.
(b) Such reports shall be submitted
either electronically through Center for
Devices and Radiological Health
eSubmitter or addressed to the Food and
Drug Administration, Center for Devices
and Radiological Health, ATTN:
Accidental Radiation Occurrence
Reports, Document Mail Center, 10903
New Hampshire Ave., Bldg. 66, rm.
G609, Silver Spring, MD 20993–0002,
and the reports and their envelopes
shall be distinctly marked ‘‘Report on
1002.20’’ and shall contain all of the
following information where known to
the manufacturer:
(1) The nature of the accidental
radiation occurrence;
(2) The location at which the
accidental radiation occurrence
occurred;
(3) The manufacturer, type, and
model number of the electronic product
or products involved;
(4) The circumstances surrounding
the accidental radiation occurrence,
including causes;
(5) The number of persons involved,
adversely affected, or exposed during
the accidental radiation occurrence, the
nature and magnitude of their exposure
and/or injuries and, if requested by the
Director, Center for Devices and
Radiological Health, the names of the
persons involved;
(6) The actions, if any, which may
have been taken by the manufacturer, to
control, correct, or eliminate the causes
and to prevent reoccurrence; and
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(7) Any other pertinent information
with respect to the accidental radiation
occurrence.
(c) If a manufacturer:
(1) Is required to report to the Director
under paragraph (a) of this section and
also is required to report under part 803
of this chapter, the manufacturer shall
report in accordance with part 803; or
(2) Is required to report to the Director
under paragraph (a) of this section and
is not required to report under part 803
of this chapter, the manufacturer shall:
(i) Immediately report incidents
associated with a death or serious injury
in accordance with paragraphs (a) and
(b) of this section; and
(ii) Either immediately report
incidents not associated with a death or
serious injury individually or compile
such incidents for submission in a
quarterly summary report with tracking
and trending analysis of that data in
accordance with paragraphs (a) and (b)
of this section. The quarterly report
must cover information required under
paragraphs (b)(1) through (7) of this
section for each occurrence were known
to the manufacturer. Occurrences may
be grouped to identify the most common
circumstances and potential cause(s),
including but not limited to, design
changes, manufacturing, or user.
Planned mitigation(s) with an
assessment of effectiveness, or a
justification for why mitigation is not
necessary, must be associated with each
occurrence or grouping of similar
occurrences. A manufacturer need not
file a separate report under this section
if an incident involving an accidental
radiation occurrence is associated with
a defect or noncompliance and is
reported pursuant to § 1003.10 of this
chapter.
PART 1010—PERFORMANCE
STANDARDS FOR ELECTRONIC
PRODUCTS: GENERAL
8. The authority citation for part 1010
continues to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e360j, 360hh-360ss, 371, 381.
9. Amend § 1010.2 by adding
paragraph (e) to read as follows:
■
§ 1010.2
Certification.
*
*
*
*
*
(e) Laser products under § 1040.10 of
this chapter that incorporate a certified
laser system (laser product) will be
considered to have met the certification
PO 00000
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Fmt 4700
Sfmt 4700
requirements in this section if all of the
following conditions are met:
(1) The incorporated laser system is
not a laser product intended for use as
a component or replacement as
described in § 1040.10(a)(1) and (2) of
this chapter;
(2) The manufacturer of the
incorporated laser system has certified
such laser system under this section and
meets the reporting requirements under
part 1002 of this chapter;
(3) The product incorporating the
certified laser system is not
independently subject to additional
reporting or performance standards
requirements;
(4) The incorporated laser system is
not modified as defined in § 1040.10(i)
of this chapter, and all performance
features that apply to the incorporated
laser system under § 1040.10(f) are
available on the product incorporating
the certified laser system;
(5) All labeling requirements that
apply to the incorporated laser system
under §§ 1010.2, 1010.3, 1040.10(g), and
1040.11(a)(3) of this chapter are visible
on the outside of the product
incorporating the certified laser system,
with the exception that the certification
or identification labels need not be
visible on the outside of products
incorporating a certified Class I laser;
(6) The incorporated laser system is
installed in accordance with the
instructions provided by the
manufacturer of the incorporated laser
system, including instructions for
placing additional externally facing
labels found in paragraph (e)(5) of this
section, and meeting the other
conditions in paragraphs (e)(1) through
(8) of this section;
(7) The manufacturer of the product
that incorporates the laser system
provides the end user with information
required under § 1040.10(h)(1) of this
chapter as provided to them by the
manufacturer of the incorporated laser
system; and
(8) The labeling requirements under
part 1010 and § 1040.10(g) of this
chapter for the incorporated laser
system would be met in any service
configuration of the product
incorporating the laser system or when
the incorporated laser system is
removed from the product into which it
had been incorporated, and
reproductions of such labels are found
in the user information.
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Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Rules and Regulations
10. Amend § 1010.3 by revising
paragraph (a)(2)(ii) to read as follows:
14. Amend § 1020.30 by revising
paragraphs (d)(1) and (d)(2)(ii) to read as
follows:
■
§ 1010.3
■
Identification.
*
*
*
*
*
(a) * * *
(2) * * *
(ii) The month and year of
manufacture shall be provided clearly
and legibly, without abbreviation, and
with the year shown as a four-digit
number as follows in this paragraph.
Alternatively, a manufacturer may
utilize a manufacturing symbol and date
format that conforms with an applicable
FDA recognized consensus standard.
Manufactured: (Insert Month and Year
of Manufacture.)
*
*
*
*
*
11. Amend § 1010.4 by revising
paragraphs (b) introductory text, (b)(1),
and (b)(2) introductory text to read as
follows:
■
§ 1010.4
Variances.
*
*
*
*
*
(b) Applications for variances. If you
are submitting an application for
variances or for amendments or
extensions thereof:
(1) You must either:
(i) Submit the variance application
and supporting materials to CDRH by
email using the
RadHealthCustomerService@
fda.hhs.gov mailbox; or
(ii) Submit an original copy of the
variance application by mail to: U.S.
Food and Drug Administration, Center
for Devices and Radiological Health,
Document Mail Center, Bldg. 66, Rm.
G609, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002.
(2) The application for variance shall
include the following information:
*
*
*
*
*
PART 1020—PERFORMANCE
STANDARDS FOR IONIZING
RADIATION EMITTING PRODUCTS
Authority: 21 U.S.C. 351, 352, 360e–360j,
360hh–360ss, 371, 381.
13. Amend § 1020.10 by revising
paragraph (a) to read as follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 1020.10 Television receivers with
cathode ray tubes.
(a) Applicability. The provisions of
this section are applicable to television
receivers with cathode ray tubes
manufactured subsequent to January 15,
1970.
*
*
*
*
*
Jkt 259001
*
*
*
*
(d) * * *
(1) Reports of assembly. All
assemblers who install certified
components shall file a report of
assembly, except as specified in
paragraph (d)(2) of this section. The
report will be construed as the
assembler’s certification and
identification under §§ 1010.2 and
1010.3 of this chapter. The assembler
shall affirm in the report that the
manufacturer’s instructions were
followed in the assembly or that the
certified components as assembled into
the system meet all applicable
requirements of §§ 1020.30 through
1020.33. All assembler reports must be
on a form (Form FDA 2579 made
available at https://www.fda.gov/aboutfda/reports-manuals-forms/forms)
prescribed by the Director, Center for
Devices and Radiological Health.
Completed reports must be submitted to
the purchaser and, where applicable, to
the State agency responsible for
radiation protection within 15 days
following completion of the assembly.
(2) * * *
(ii) Certified accessory components;
*
*
*
*
*
PART 1030—PERFORMANCE
STANDARDS FOR MICROWAVE AND
RADIO FREQUENCY EMITTING
PRODUCTS
15. The authority citation for part
1030 continues to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360, 360e–
360j, 360hh–360ss, 371, 381.
16. Amend § 1030.10 by revising
paragraph (c)(6)(iv) introductory text as
follows:
■
Microwave ovens.
*
12. The authority citation for part
1020 continues to read as follows:
15:54 Jan 19, 2023
*
§ 1030.10
■
VerDate Sep<11>2014
§ 1020.30 Diagnostic x-ray systems and
their major components.
*
*
*
*
(c) * * *
(6) * * *
(iv) Upon application by a
manufacturer, the Director, Center for
Devices and radiological Health, Food
and Drug Administration, may grant an
exemption from one or more of the
statements (radiation safety warnings)
specified in paragraph (c)(6)(i) of this
section. Such exemption shall be based
upon a determination by the Director
that the microwave oven model for
which the exemption is sought should
continue to comply with paragraphs
(c)(1) through (3) of this section under
the adverse condition of use addressed
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
by such precautionary statement(s). An
application shall be submitted to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852. Copies of the written portion of
the application, including supporting
data and information, and the Director’s
action on the application will be
maintained by the Dockets Management
Branch for public review. The
application shall include:
*
*
*
*
*
PART 1050—[REMOVED AND
RESERVED]
17. Under the authority of 21 U.S.C.
351, 352, 360, 360e–360j, 360hh–360ss,
371, 381, part 1050 is removed and
reserved.
■
Dated: January 4, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023–00922 Filed 1–19–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Office of Justice Programs
28 CFR Part 94
[Docket No.: OJP (OVC) 1539]
RIN 1121–AA78
International Terrorism Victim Expense
Reimbursement Program
Office of Justice Programs,
Justice.
ACTION: Adoption of interim rule as
final; technical corrections.
AGENCY:
The Office for Victims of
Crime (‘‘OVC’’) is promulgating this
final rule for its International Terrorism
Victim Expense Reimbursement
Program (‘‘ITVERP’’), in order to finalize
the interim final rule published on April
11, 2011, which removed a regulatory
limitation on the discretion of the
Director of OVC to accept claims filed
more than three years after the date that
an incident is designated as an incident
of international terrorism. This final
rule also makes non-substantive
technical corrections to update citations
to reflect the current location of the
cited provisions.
DATES: This final rule is effective
January 20, 2023.
ADDRESSES: For further information, see
the ITVERP website at https://
www.ojp.usdoj.gov/ovc/intdir/itverp.
FOR FURTHER INFORMATION CONTACT:
Victoria Jolicoeur, ITVERP, Office for
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3638-3654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1000, 1002, 1010, 1020, 1030 and 1050
[Docket No. FDA-2018-N-3303]
RIN 0910-AH65
Radiological Health Regulations; Amendments to Records and
Reports for Radiation Emitting Electronic Products; Amendments to
Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
amending and repealing parts of the radiological health regulations
covering recommendations for radiation protection during medical
procedures, certain records and reporting for electronic products, and
performance standards for diagnostic x-ray systems and their major
components, laser products, and ultrasonic therapy products. The Agency
is taking this action to clarify and update the regulations to reduce
regulatory requirements that are outdated and duplicate other means to
better protect the public health against harmful exposure to radiation
emitting electronic products and medical devices.
DATES: This rule is effective February 21, 2023.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert Ochs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3680, Silver Spring, MD 20993, 301-796-6661, email:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits of the Final Rule
II. Table of Abbreviations/Commonly Used Acronyms
III. Background
A. Need for Amendments and Repeal of Certain Radiological Health
Regulations
B. Summary of Comments to the Proposed Rule
C. General Overview of Final Rule
IV. Legal Authority
V. Comments to the Proposed Rule and FDA's Responses
A. General Comments on the Proposed Rule
B. Radiation Safety Recommendations/Standards Comments
C. General Format and Edit Comments
D. Records and Reports Comments
E. Reports of Assembly, Forms, and Guidance Comments
F. Accidental Radiation Occurrences Comments
G. Laser Comments
VI. Effective Date
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
C. Summary of Regulatory Flexibility Analysis
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule amends and repeals certain regulations for
radiation emitting electronic products and medical devices because the
FDA has identified the regulations as being outdated and duplicative of
other means for reducing radiation exposure to the public. The Agency
is updating the regulations to amend or repeal regulations that are
outdated and otherwise clarify requirements for protecting the public
health against radiation exposure from specific electronic products and
medical devices. The regulations being finalized for amendment or
repeal are the radiation protection recommendations for specific uses,
records and reporting requirements for electronic products,
applications for variances, and performance standards for diagnostic x-
ray systems and their major components, laser products, and ultrasonic
therapy products.
B. Summary of the Major Provisions of the Final Rule
This final rule updates FDA's radiological health regulations to
amend or repeal the following provisions:
Repeal the radiation protection recommendations that have
become outdated and unnecessary;
Removing or reducing some of the annual reports and test
record
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requirements that are unnecessary or may be duplicative of other
reporting requirements by FDA and State regulators;
Revise the timing for submissions of reporting
requirements for accidental radiation occurrences (AROs) to provide for
quarterly reporting for AROs that are not associated with a death or
serious injury;
Amend the applications for variances processes to no
longer require a manufacturer to submit two additional copies with the
original documents;
Amend the regulations to no longer require assemblers who
install certified components of diagnostic x-ray systems to submit
reports of assembly to the Agency;
Amend the reporting requirements for manufacturers that
incorporate a certified laser product to reduce reporting that is
considered duplicative under certain conditions; and
Repeal the performance standard for ultrasonic products
because it is limited to a subset of physical therapy devices with an
outdated standard.
The Agency believes the amendments and repeals will help to ensure
that the requirements for radiation emitting electronic products and
devices will continue to protect the public health and safety while
reducing regulatory burdens.
C. Legal Authority
FDA is issuing this final rule under the same authority under which
FDA initially issued these regulations, the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). FDA has the authority under the FD&C Act to amend the
performance standard for diagnostic x-ray systems and their major
components, amend the performance standard for laser products, and
repeal radiation protection recommendations and the performance
standard for ultrasonic therapy products, as provided for in this rule.
D. Costs and Benefits of the Final Rule
This final rule updates FDA's radiological health regulations by
amending parts of the general provisions including records and
reporting requirements for electronic products. Benefits are estimated
in terms of cost savings. Industry cost savings are derived by
estimating the savings in reduced labor resulting from the reduction in
reporting, recordkeeping, and third-party disclosure requirements. Cost
savings to FDA result from the reduction in labor hours required to
review reports. The total present value cost savings over a 20-year
time period are $69.71 million at a 7 percent discount rate and $97.89
million at a 3 percent discount rate. Annualized total cost savings are
$6.58 million. We estimate the costs to read the rule for all reporting
respondents. The present value costs are $1.60 million and the
annualized costs calculated over a 20-year time period are $0.14
million at a 7 percent discount rate and $0.10 million at a 3 percent
discount rate.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation What it means
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ARO........................................................... Accidental Radiation Occurrences.
CDRH.......................................................... Center for Devices and Radiological Health.
CFR........................................................... Code of Federal Regulations.
CRCPD......................................................... Conference of Radiation Control Program
Directors.
CT............................................................ Computerized Tomography.
EO............................................................ Executive Order.
EPRC.......................................................... Electronic Product Radiation Control.
EPA........................................................... Environmental Protection Agency.
FD&C Act...................................................... Federal Food, Drug, and Cosmetic Act.
FDA, Agency or we............................................. Food and Drug Administration.
ICRP.......................................................... International Commission on Radiological
Protection.
IEC........................................................... International Electrotechnical Commission.
ISO........................................................... International Organization for Standardization.
MDR........................................................... Medical Device Reporting.
NCRP.......................................................... National Council on Radiation Protection and
Measurements.
OMB........................................................... Office of Management and Budget.
PRA........................................................... Paperwork Reduction Act of 1995.
TEPRSSC....................................................... Technical Electronic Product Radiation Safety
Standards Committee.
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III. Background
FDA recognizes that some records and reporting requirements for
some radiation emitting electronic products and medical devices are not
necessary to protect the public health and safety in compliance with
the Electronic Product Radiation Control (EPRC) program (see sections
532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. 360ii,
360kk(a)(1), and 360nn(b))). In addition, some of the recommended
protections against radiation and performance standards are now
outdated and redundant to other Federal and State requirements,
including professional guidelines that apply to the education and
licensing of practitioners, as well numerous current radiation guidance
documents and industry standards that practitioners and industry rely
on to protect the public health and safety. For example, there are more
recent standards that industry and FDA can rely on for the safety of
ultrasonic therapy devices for physical medicine, for instance the
International Electrotechnical Commission (IEC) standards 60601-2-5,
Medical electrical equipment--Part 2-5: Particular requirements for the
basic safety and essential performance of ultrasonic physiotherapy
equipment (August 6, 2013) and 61689, Ultrasonics--Physiotherapy
systems--Field specifications and methods of measurement in the
frequency range 0.5 MHz to 5 MHz (January 30, 2014). FDA also
recognizes that submission of certain quarterly reports is unnecessary
given certain annual reporting requirements. In addition, the
submission of initial product reports for products that are also
subject to premarket authorization prior to marketing is duplicative.
The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on
November 28, 1990, transferred the provisions of the Radiation Control
for Health and Safety Act of 1968 (Pub. L. 90-602) (formerly 42 U.S.C.
263b through n(i) et seq.) from Title III of the Public Health Service
Act to Chapter V, subchapter C of the FD&C Act, EPRC (sections 531-542
of the FD&C Act (21 U.S.C. 360hh-360ss)). Under these provisions, FDA
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administers the EPRC program to protect the public health and safety.
This authority provides for developing, amending, and administering
radiation safety performance standards for electronic products.
FDA is responsible for protecting and promoting the public health
regarding electronic product radiation from medical devices and
electronic products. Voluntary consensus standards regarding safety and
essential performance have been developed and continually improved to
increase the safety of these devices and products (sections 514(c) (21
U.S.C. 360d) and 531-542 of the FD&C Act). FDA believes radiation
emitting electronic products and devices that comply with Federal
standards and Federally-recognized consensus standards, adequately
protect the public health and safety and provide a reasonable assurance
of safety and effectiveness, as applicable, when properly used by
trained personnel, and concern has shifted to minimizing improper uses.
FDA, patients, health workers, and industry recognize that medical
products that emit radiation should be used only when medically
justified to answer a clinical question or to guide treatment of a
disease, and that the amount of radiation used should be limited to
that necessary to accomplish the clinical task (Refs. 1, 2-4).
In 2010, FDA's Center for Devices and Radiological Health (CDRH)
launched an ``Initiative to Reduce Unnecessary Radiation Exposure from
Medical Imaging'' (Ref. 3) to protect public health by promoting the
appropriate use of radiation and safety features to minimize
unnecessary radiation exposure from medical imaging. Through this
initiative, FDA collaborates with other agencies and the healthcare
professional community to mitigate factors contributing to unnecessary
patient exposure to radiation during medical procedures. The range of
electronic products marketed today is diverse with regards to radiation
emission levels, product complexity, consumer use, and sales volume.
The public risk associated with exposure to radiation from these
products also varies significantly; however, the risks to patients can
be mitigated by medical personnel only performing exams using radiation
when necessary to answer a medical question, treat a disease, or guide
a procedure (Ref. 4).
In accordance with FDA's directive to carry out the EPRC program
(see sections 532, 534(a)(1), and 537(b) of the FD&C Act), FDA
prescribes and amends performance standards for electronic products to
control the emission of electronic product radiation when necessary to
protect the public health and safety. In establishing performance
standards consistent with the statute, FDA consulted with the Technical
Electronic Product Radiation Safety Standards Committee (TEPRSSC)
(section 534(f) of the FD&C Act) (Ref. 5). On October 26, 2016, a
TEPRSSC meeting was held and FDA presented, for consultation with
TEPRSSC, proposed certain amendments to the regulations for laser,
sonic, x-ray, and other radiation emitting products to best align FDA's
focus with the public health need and reduce or eliminate standards or
reporting that were no longer considered necessary (Ref. 5). FDA also
proposed to the TEPRSSC the removal of the ultrasonic therapy
performance standard with continuing reliance on medical device review
prior to marketing authorization. Items in these amendments have been
considered in discussions by TEPRSSC as necessary. Therefore, FDA has
determined that the regulatory requirements can be adjusted to take
account of the wide range of electronic products currently on the
market and focus on products that pose a higher risk to the public.
A. Need for Amendments and Repeal of Certain Radiological Health
Regulations
Many of the requirements in our radiological health regulations are
over 30 years old. As described below and in the proposed rule (84 FR
12147, April 1, 2019) the final rule amends and repeals certain
radiological health regulations to reduce regulatory requirements that
are outdated and duplicative. Specifically, this final rule amends
parts of the radiological health regulations covering recommendations
for radiation protection during medical procedures, certain records and
reporting for electronic products, applications for variances, and
performance standards for diagnostic x-ray systems and their major
components, laser products, and ultrasonic therapy products while still
assuring the public health and safety is protected against harmful
exposure to radiation emitting electronic products and medical devices.
B. Summary of Comments to the Proposed Rule
In the Federal Register of April 1, 2019, FDA published a proposed
rule to amend the radiological health regulations (84 FR 12147). The
comment period for the proposed rule closed on July 1, 2019. FDA
received comments on the proposed rule from several entities including
medical device associations, industry, medical and healthcare
professional associations, public health advocacy groups, and
individuals. While some comments object to particular sections or
subsections of the proposed rule, almost all comments voice support for
the objective intent of the proposed rule, to amend certain regulations
to reduce regulatory burden while continuing to assure protection of
the public health and safety against harmful exposure to radiation
emitting electronic products and medical devices.
Some comments raise concerns or request clarification regarding:
repealing the radiation protection recommendations,
removing or reducing certain records and reporting
requirements for electronic products,
incorporating and expanding the policies described in
FDA's Laser Notice 42 to higher powered laser products,
amending the performance standards for laser products that
incorporate certified laser systems,
information on future technologies and other measures that
may reduce or eliminate radiation exposure,
document retention and responsibilities related to
initial, supplemental, abbreviated and annual reports,
assemblers' responsibilities for maintaining a record of
report of assembly on file,
the tracking and trending analysis related to the
requirements for reports on accidental radiation occurrences, and
additional amendments to performance standards for laser
products.
C. General Overview of Final Rule
FDA considered all comments received on the proposed rule and made
changes, primarily for clarity and accuracy and to be consistent with
the goal of reducing the burden of regulatory requirements for
radiation emitting products and medical devices without compromising
patient safety. On its own initiative, FDA is also making minor
technical changes to improve clarity and consistency and reduce
regulatory burden. Based on the comments received on the proposed rule,
FDA has made changes from the proposed rule (84 FR 12147) to include
the following revisions in the codified section of this final rule:
Include the word ``accidental'' in the definition for
radiation occurrence (Sec. 1000.3(a)),
include a footnote in the records and reports table
clarifying laser product certification (table 1 in Sec. 1002.1),
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include language of information needed for quarterly
reporting of accidental radiation occurrences (Sec.
1002.20(c)(2)(ii)),
include a paragraph with language to identify when
certification and reporting is duplicative and unnecessary for laser
products under Sec. 1040.10 that incorporate a certified laser system
(Sec. 1010.2(e)),
identify an alternative format for identification of the
month and date of the manufacture of an electronic product (Sec.
1010.3(a)(2)(ii)),
clarify the options for submissions for applications for
variances (Sec. 1010.4(b)(1)), and
revise the title and applicability for television
receivers that contain a cathode ray tube (Sec. 1020.10).
FDA also decided on its own initiative to include the following
additional amendments to this final rule for clarity and consistency
and to reduce regulatory burden:
remove the requirement for two copies of an application
for exemption of warning labels for a microwave oven that are submitted
to CDRH and correct the name of the CDRH office to submit a document
(Sec. 1030.10(c)(iv)), and
clarify and remove the requirement that x-ray assemblers
for certified accessory components submit Reports of Assembly (Form FDA
2579) to CDRH (Sec. 1020.30(d)(2)).
IV. Legal Authority
FDA is issuing this final rule under the same authority under which
FDA initially issued these regulations, the device and general
administrative provisions of the FD&C Act (21 U.S.C. 321, 351, 352,
360, 360e-360j, 360hh-360ss, 371, 374, and 381). FDA has the authority
under section 534 of the FD&C Act to amend the performance standard for
diagnostic x-ray systems and their major components, amend the
performance standard for laser products, and repeal radiation
protection recommendations and the performance standard for ultrasonic
therapy products, as provided for in this final rule.
V. Comments on the Proposed Rule and FDA's Responses
We received several sets of comments on the proposed rule by the
closure of the comment period, each containing one or more comments on
one or more issues. We received comments from medical device
associations, industry, medical and healthcare professional
associations, public health advocacy groups, and individuals. We
describe and respond to the comments in this section of the document.
The topics for the comments are grouped based on the common themes
identified below. We have grouped similar comments together under the
same number so that FDA's responses could be addressed by topic,
instead of each comment addressed independently, and, in some cases, we
have separated different issues discussed in the same comment and
designated them as distinct comments for purposes of our responses. The
number assigned to each comment or comment topic is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which comments were received.
A. General Comments on the Proposed Rule
(Comment 1) FDA received multiple comments that express support for
the proposed rule and the proposals to remove outdated radiation
protection recommendations and adjust the regulatory records and
reporting requirements based on risk. The comments urged the Agency to
maintain vigilance and continue to promote the health and safety of
patients and healthcare practitioners.
(Response 1) FDA appreciates the public support for the rule. FDA
intends to continue to utilize its regulatory authorities and
collaborations with other governmental agencies, non-governmental
organizations, and industry, among others, to promote the safe and
effective use of radiation to best protect and promote public health.
B. Radiation Safety Recommendations/Standards Comments
(Comment 2) One comment referenced multiple publications that
supported FDA's proposal that the recommendations in Sec. 1000.50 for
use of gonad shielding were inconsistent with current scientific
evidence and should be removed.
(Response 2) FDA agrees with the recommendation and is removing the
recommendations in Sec. 1000.50 in this final rule.
(Comment 3) One comment raised concern that by repealing the
radiation protection recommendations, end-users may have difficulty
finding, analyzing, and applying the appropriate standards and
practices to specific clinical healthcare situations. The comment
requested that FDA list the specific regulations that are outdated or
duplicative and provide direction as to the appropriate current
standards or practice parameters that replace the repealed regulations.
(Response 3) FDA acknowledges the concern but does not believe that
repeal of the recommendations will cause difficulty in locating and
applying applicable standards and practices. This final rule identifies
the Sec. 1000.50 recommendations that are being removed. FDA believes
these specific recommendations are outdated and no longer relied upon
by healthcare providers. Removing the recommendations eliminates
information that is no longer useful. FDA identified recent, consensus
recommendations in the proposed rule (Refs. 1, 2, 6-9). FDA continues
to recommend that medical professionals also seek continuing education
through professional societies to remain current with new technologies,
standards, and best practice guidelines.
(Comment 4) Multiple comments recognized the contributions of
external stakeholders to develop and incorporate radiation protection
into device design, practitioner training, and best practices for
standards of care. Comments stated that diagnostic imaging is an
important part of the standard of care, and training and continuing
education are important so that healthcare professionals know the
rules, regulations, safety procedures, and best practices to benefit
patients and avoid harm. The comments requested that FDA support and
reference the most relevant guidelines for healthcare professionals
wherever feasible.
(Response 4) FDA recognizes the importance of training and
continuing education for healthcare professionals and will continue to
collaborate with, and reference the work of, external organization as
appropriate to develop standards. FDA believes professional societies
should have the resources and knowledge to provide the most up-to-date
guidelines for their members. FDA recognizes the significant and
ongoing contributions that external stakeholders, such as the American
Association of Physicists in Medicine, the American College of
Radiology, the Health Physics Society, the Image Gently Alliance, the
International Atomic Energy Agency, the Medical Imaging Technology
Alliance, the Society of Interventional Radiology, the World Health
Organization, and many others, have made to incorporate radiation
protection into device design, practitioner training, and best
practices for standards of care. For example, in 2003, the National
Council on Radiation Protection and Measurements (NCRP) updated its
recommendations on radiation protection in dentistry (Ref. 6). In 2012,
the American Dental Association, in conjunction with FDA, updated its
selection criteria for dental imaging with guidelines for the frequency
of
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dental radiographs and radiation exposure recommendations (Ref. 7). In
2014, the Environmental Protection Agency's (EPA) Working Group on
Medical Radiation, with active FDA participation, published a document
entitled ``Federal Guidance Report No. 14. Radiation Protection
Guidance for Diagnostic and Interventional X-Ray Procedures'' (Guidance
Report No. 3), which provides comprehensive recommendations for
radiation protection to medical and dental facilities (Ref. 1). Because
safety procedures and best practices are continuously revised and
improved, FDA believes that specifically referencing existing
guidelines in the regulations is not appropriate because it may lead to
confusion or unintended consequences as practice guidelines continue to
be updated.
(Comment 5) One comment acknowledges that professional
organizations play a key role in developing guidance for safe use of
radiation, but such guidance may not be comprehensive. The comment
recommended that FDA define the organizational credentials and
processes to guide the development and format of radiation use
standards.
(Response 5) FDA disagrees with the recommendation because the EPRC
does not provide for defining and enforcing criteria by which standards
organizations or professional societies operate (see sections 532,
534(a)(1), and 537(b) of the FD&C Act). FDA's standards program
provides FDA with the opportunity to review and rely on appropriately
developed standards within the scope of the FD&C Act. FDA actively
participates in the development of voluntary standards and guidelines
with other organizations. FDA encourages individuals and professional
societies to join and participate in the development of safety
recommendations and standards to address the diversity of clinical,
scientific, and other needs that apply to their profession.
(Comment 6) One comment suggested that one national set of
standards, regulations and training requirements for operators is
preferable to differences by state or locality. The comment included a
specific example that the quality of dental radiography may vary given
the lack of national requirements, especially with the introduction of
new technologies, such as cone-beam Computerized Tomography (CT). The
lack of a national standard may result in different approaches to
radiographer training, with the potential for increased radiation
exposure to patients. The comment recommended that FDA designate a
specific organization as the responsible entity on all aspects of
dental imaging including training of all dental personnel who perform
dental imaging examinations.
(Response 6) FDA disagrees with the recommendation. The EPRC does
not provide for defining and enforcing criteria by which standards
organizations or professional societies operate, or for designating an
organization(s) to define or enforce such requirements. FDA notes that
such standards and training are generally provided for by appropriate
organizations and professions, and FDA frequently collaborates with
these organizations and professions. FDA supports the continuation of
such efforts by these entities to educate members on best practices for
safe use of radiation in their profession. For dental imaging
specifically, FDA, in collaboration with the Conference of Radiation
Control Program Directors (CRCPD), recently completed a nationwide
survey of the use of radiation in dental imaging facilities (Ref. 10).
FDA staff participated in developing a report by the National Council
on Radiation Protection and Measurements (NCRP) on radiation protection
in dentistry (Ref. 11). FDA has also collaborated with the American
Dental Association on guidelines for the selection of patients for
dental radiographic examinations (Ref. 7). FDA hopes the results of
these kinds of collaborations, and other work from similar
organizations, will help inform FDA and other organizations of best
practices and recommendations for training and equipment standards.
(Comment 7) One comment recommended FDA withdraw the rules and
regulations for the lowest risk radiation emitting electronic products
first. The commenter suggested removing reporting of assembly for wall
mounted x-ray generators for intraoral radiography, while maintaining
reporting for handheld portable x-ray generators for use in dentistry,
which are relatively new and without the same safety record.
(Response 7) FDA disagrees with the comment. FDA has taken a risk-
based assessment in amending the regulations. FDA considers submission
to FDA of any report of assembly for certified components of diagnostic
x-ray products to no longer be necessary, while continuing to
facilitate the submission of such reports of assembly, where
applicable, to State agencies and purchasers. Diagnostic x-ray systems
still need to meet the product-specific performance standards under
part 1020 (21 Code of Federal Regulations (CFR), part 1020), including
the submission of any reports of assembly of installed certified
components as applicable. Diagnostic x-ray systems, including handheld
dental x-ray units, will also continue to be subject to applicable
medical device regulations (see, e.g., 21 CFR parts 803, 807, 820, 872,
and 892).
(Comment 8) Some comments support the use of international
voluntary consensus standards to help ensure regulatory requirements
are met. Commenters noted the benefits, including consistency in
regulation, global harmonization, efficiencies, minimizing unnecessary
costs and delays in patient access to innovative new devices and
promoting safety, and consistency with the National Technology Transfer
and Advancement Act (Pub. L. 104-113), and Office of Management and
Budget's (OMB) directive Circular A-119, Federal Participation in the
Development and Use of Voluntary Consensus Standards and in Conformity
Assessment Activities (Ref. 12).
(Response 8) FDA agrees with these comments and will continue to
participate in the development of international standards and their use
for regulatory purposes as appropriate.
(Comment 9) One comment expressed interest in FDA providing
information on future technologies and other measures that may reduce
or eliminate radiation exposure.
(Response 9) FDA recommends that medical professionals seek
continuing education through their appropriate professional societies
to maintain knowledge of new technologies and best practice guidelines.
With respect to medical devices, FDA's Q-Submission Program (Ref. 13)
offers manufacturers the opportunity to receive feedback on their
proposed regulatory pathway and test plans when developing new devices
and technologies that may improve image quality and patient safety.
C. General Format and Edit Comments
(Comment 10) One comment recommended reformatting table 1 of Sec.
1002.1 for clarity by merging and shading the category rows.
(Response 10) FDA understands the concern for readability of the
regulations; however, FDA is limited in the formatting tools available
for display and printing of regulations in the Federal Register and the
CFR, as such stylistic issues are determined by the U.S. Government
Publishing Office for the entire Federal government. The information
will continue to be displayed in table 1 as formatted and published in
the proposed rule.
(Comment 11) One comment recommended clarifying in Sec. Sec.
1002.20(b) and 1010.4(b) whether
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submission of both electronic and paper reports and variance requests
are acceptable.
(Response 11) FDA agrees with the recommendation and is revising
the language in Sec. Sec. 1002.20(b) and 1010.4(b) to clarify that
``either'' electronic or paper submissions are appropriate.
(Comment 12) One comment recommended that the regulations allow for
use of the International Organization for Standardization (ISO)
standard date format (``YYYY-MM-DD''), which is required for medical
devices in 21 CFR 801.18(a), as an alternative to the EPRC format
specified in Sec. 1010.3(a)(2)(ii).
(Response 12) FDA agrees with the recommendation and is revising
the regulation to alternatively provide for use of a manufacturing
symbol and date format that is in accordance with applicable FDA
recognized consensus standards, such as ISO 7000: Graphical symbols for
use on equipment and IEC 60417: Graphical symbols for use on equipment
(Ref. 14) (see Sec. 1010.3(a)(2)(ii) of this final rule).
D. Records and Reports Comments
(Comment 13) One comment requested clarification of the document
retention requirements related to initial (Sec. 1002.10), supplemental
(Sec. 1002.11), abbreviated (Sec. 1002.12), and annual reports (Sec.
1002.13). The Agency was asked to state clearly that manufacturers will
no longer need to generate and retain these reports.
(Response 13) The proposed rule modified table 1 (Sec. 1002.1) to
show that manufacturers of diagnostic x-ray products would no longer
need to submit initial (Sec. 1002.10), supplemental (Sec. Sec.
1002.11), abbreviated (Sec. 1002.12), and annual reports (Sec.
1002.13). In the final rule, we are maintaining this change. As a
result, manufacturers of diagnostic x-ray systems will no longer need
to generate and retain such reports related to diagnostic x-ray
systems. To clarify, this modification would not remove these
requirements for all products listed under table 1 (Sec. 1002.1 of
this final rule). Many other reporting and recordkeeping requirements
are unchanged including, as applicable based on the requirements in
Sec. 1002.1, the requirements for test and distribution records
specified in Sec. 1002.30.
(Comment 14) One comment requested that FDA clarify if an annual
report would still be required for a diagnostic x-ray system that falls
within this category due to its display being classified as a
television product (Sec. 1020.10). The comment suggested removing the
reporting requirements for such displays that are included in
diagnostic x-ray systems.
(Response 14) FDA appreciates the comment and recognizes there may
be confusion about reporting requirements for diagnostic x-ray systems
that include television displays. FDA agrees that reporting should not
be required for medical device manufacturers of diagnostic x-ray
systems that use modern display technologies (e.g., light emitting
diode and liquid crystal display) that do not incorporate a cathode ray
tube display. However, FDA believes that the reporting requirement
should be maintained for displays that do contain a cathode ray tube,
and were manufactured subsequent to January 15, 1970, because these
types of displays generate ionizing radiation during use. FDA is
therefore amending Sec. 1020.10(a) to clarify that the television
product performance standard (and thus reporting requirements) only
applies to televisions/displays that contain a cathode ray tube. FDA
believes EPRC reporting for such older technologies is necessary for
the public health and safety to monitor the use of cathode ray tubes in
televisions/displays. Given the outdated nature of the cathode ray tube
technology, at this time, FDA believes this type of television display
included in diagnostic x-ray systems is the only type that would
continue to benefit from the annual reporting requirement. Therefore,
FDA does not believe that excluding this type of television display
product from the reporting requirements is appropriate at this time.
(Comment 15) One comment requested FDA to clarify how the changes
in reporting would impact the process for manufacturers to receive
accession numbers, which are used for customs clearance.
(Response 15) Manufacturers of diagnostic x-ray systems that are no
longer required to submit product reports, and who therefore will no
longer receive an accession number, will no longer need to submit an
accession number when importing products (see Sec. 1002.1, table 1 of
this final rule). The import process for diagnostic x-ray systems will
be the same as for other medical devices that do not require submission
of product reports. Manufacturers can refer to FDA's website for more
information on the imports process and program (Ref. 15).
(Comment 16) One comment mentioned the concern that if the records
and reporting requirements for electronic products and medical devices
are removed or reduced, then end-users will rely on state requirements,
which may not have changed in many years. The comment raised concerns
that in some states, repealing regulations for records and reporting
requirements for electronic products and medical devices may be
catastrophic if a recall on ionizing radiation equipment were issued.
(Response 16) FDA believes recordkeeping is important in case of
recalls and that compliance with all applicable performance standards
is important to ensure the protection of the public health and safety.
The amendments do not change FDA's authority or a manufacturer's
responsibilities if a product is defective or fails to comply with
performance standards under section 534 of the FD&C Act. The final rule
does not change any of the manufacturer, dealer, or distributer
recordkeeping requirements under Sec. Sec. 1002.1, 1002.30, 1002.40,
or 1002.41 that are used to notify potentially impacted persons. The
final amendments also do not change the reporting, notification, and
requirements to perform corrective actions under part 1003 (21 CFR part
1003) for electronic product defects or failure to comply with a
performance standard. Lastly, the amendments do not change any of the
regulations applicable to the recall of medical devices under 21 CFR
part 806. Therefore, FDA disagrees that it would be catastrophic if a
recall on ionizing radiation equipment were issued following these
amendments.
E. Reports of Assembly, Forms, and Guidances Comments
(Comment 17) Some comments supported amending the regulations to no
longer require assemblers who install certified accessory components of
diagnostic x-ray systems to submit reports of assembly (Form FDA 2579)
to FDA.
(Response 17) FDA agrees with the comment. In this rulemaking, FDA
is removing the requirement to submit a copy of Form FDA 2579 to FDA.
Assemblers will still be required to submit a copy to the purchaser,
and, where applicable, to state agencies responsible for radiation
protection.
(Comment 18) One comment requested clarification on whether FDA
will continue to make available Form FDA 2579 for manufacturers to use
for submitting to states and purchasers. A comment also suggested that
the form be made available in a PDF fillable format and that it retain
a document control number field.
(Response 18) FDA agrees with this request and is revising Sec.
1020.30(d)(1) to specify that Form FDA 2579 is available online. FDA
intends to make the form
[[Page 3644]]
PDF fillable and retain a field on the form for a document control
number. However, FDA does not intend to generate or specify the format
of document control numbers.
(Comment 19) One comment asked if the Agency will generate and/or
require a unique document control number for each report of assembly,
with a suggestion that manufacturers could develop a unique
identification format for the document control numbers.
(Response 19) At this time, FDA will not generate document control
numbers or define the format that manufacturers utilize. Manufacturers
are welcome to develop a standardized scheme for the document control
number if they wish.
(Comment 20) One comment requested FDA to clarify if manufacturers
will need to keep a record of the report of assembly on file.
(Response 20) Assemblers, including manufacturers who are
assembling diagnostic x-ray equipment, subject to the provisions of
Sec. 1020.30(d) will still be required under Sec. 1002.1(c)(4) to
maintain a copy of the report of assembly for 5 years.
(Comment 21) One comment requested FDA to specify what reporting
guides, forms, and guidance will be removed from the FDA website.
(Response 21) The Paperwork Reduction Act (PRA) section of this
final rule (section IX) identifies what forms will be removed or
amended. The publication of the final rule coincides with updates to
relevant FDA guidance documents for consistency with the amended
regulations.
(Comment 22) Several commenters sought clarity on reporting and
recordkeeping responsibilities associated with the changes in the
proposed rule, including any need to document reliance on recognized
consensus standards for diagnostic x-ray systems. While commenters
understood some reports and forms that would no longer need to be
submitted to FDA, there was uncertainty regarding certain requirements
to generate and maintain test records and document compliance with the
standards.
(Response 22) Manufacturers will no longer need to generate certain
specific reports to submit to FDA. In finalizing the rule, FDA is
withdrawing the reporting guides for reports that are no longer
required to be submitted. Manufacturers will still need to maintain
test and distribution records (Sec. 1002.30), where applicable. If a
manufacturer chooses to conform to applicable recognized IEC standards
in lieu of conforming to the performance standards as described in FDA
guidance (Ref. 16), then manufacturers must include in their test
records documentation specific to the scope of the corresponding
standards.
F. Accidental Radiation Occurrences Comments
(Comment 23) Several comments supported quarterly submission for
AROs that are not associated with a death or serious injury. One
comment suggested that the regulations be further amended so that
manufacturers of medical devices that are also electronic products only
need to comply with the Medical Device Reporting (MDR) requirements.
(Response 23) ARO reporting is critical for FDA to meet its
responsibility to identify and reduce unnecessary sources of radiation
exposure to the public for medical and non-medical devices. Medical
device manufacturers are required to report once they are aware of
information that reasonably suggests the medical device may have caused
or contributed to death or serious injury or there is a malfunction
that, if it were to recur, is likely to cause or contribute to a
serious injury or death (part 803 (21 CFR part 803)). Medical devices
that also meet the definition of an electronic product must also comply
with the ARO reporting requirements in Sec. 1002.20, which requires
manufacturers to report a single event, or series of events, that
resulted in injurious or potentially injurious exposure of any person
to electronic product radiation as a result of a malfunction due to the
manufacturing, testing, or use of an electronic product. The ARO
reporting program is intended to capture both serious malfunctions that
require immediate action to prevent future death or injury (which
overlaps with MDRs) and less-serious events (which may not overlap with
MDRs) where periodic reporting would help identify unnecessary
radiation exposure that may be addressed through manufacturer
correction or through revisions to safety standards. For this reason,
FDA believes ARO reporting requirements should be maintained even when
the product is subject to part 803 reporting requirements to ensure the
protection of the public health and safety under the EPRC program.
(Comment 24) One comment requested that FDA amend the regulations
to state that instances in which an exposure made by a healthcare
professional that is deemed to be clinically necessary is not an ARO
even when it is a repeat scan or image caused by a system interruption.
(Response 24) The term ``accidental radiation occurrence'' under
Sec. 1000.3(a) includes two essential aspects to such an event. First,
electronic product radiation must have been emitted. For ionizing
radiation, FDA considers the use of the linear no-threshold model
(i.e., a threshold below the amount of ionizing radiation that is not
``potentially injurious'') (Ref. 17) as a prudent and practical
approach for radiation protection. Second, the radiation emission must
have been accidental, by which the Agency means that the emission was
unintended and unexpected. An intended and expected radiation emission,
such as an intentional repeat scan or image, does not meet the
criterion of ``accidental'' and is not an ARO. To improve clarity on
this distinction, FDA is amending the definition of an ARO (Sec.
1000.3(a) in this final rule) to include the word ``accidental'' within
the definition to more clearly indicate that an ARO is an accidental
event resulting in radiation exposure. With this clarification, FDA
does not believe it is necessary to further amend the regulation by
providing specific examples involving radiation occurrences that are
not considered to be accidental.
(Comment 25) A few comments asked FDA to clarify how the tracking
and trending analysis relates to the requirements in Sec. 1002.20(a)
and (b) and what would be expected as part of this new requirement.
(Response 25) FDA acknowledges there may be confusion regarding how
the quarterly summary reporting with tracking and trending analysis
relates to the requirements under Sec. 1002.20(a) and (b). FDA is
therefore amending Sec. 1002.20 to clarify that: (1) the quarterly
report must include information required under Sec. 1002.20(b)(1)
through (7) for each occurrence where known to the manufacturer, (2)
that accidental radiation occurrences may be grouped to identify the
most common circumstances and potential cause(s), including but not
limited to, design changes, manufacturing, or user, and (3) that
planned mitigation(s) with an assessment of effectiveness, or a
justification for why mitigation is not necessary, must be associated
with each occurrence or grouping of similar occurrences (see Sec.
1002.20(c)(2)(ii) in this final rule). Such incidents should also be
evaluated to determine if the accidental radiation occurrence is the
result of a defect as defined in Sec. 1003.2 of this chapter or fails
to comply with an applicable Federal standard (see Sec. 1003.10).
Medical device manufacturers may be able to rely on information already
being generated as
[[Page 3645]]
part of their corrective and preventive actions (21 CFR 820.100).
(Comment 26) A few comments asked FDA to clarify if the tracking
and trending analysis applied to both immediate reports and quarterly
reports.
(Response 26) The submission of the tracking and trending analysis
only applies to quarterly reporting.
G. Laser Comments
(Comment 27) Several comments stated that the proposed amendments
to Sec. 1040.10 were confusing and should be clarified. The comments
raised concerns about creating a circular logic path between the text
proposed in Sec. 1040.10(a)(1), which indicates the standard is not
applicable to an uncertified laser product that is incorporated into an
electronic product that is then certified by the manufacturer, and the
certification requirements in Sec. 1010.2(a), which requires
certification when the performance standard is applicable. Commenters
stated that the term ``uncertified'' in proposed Sec. 1040.10(a)(1),
along with other edits, caused confusion because certain aspects of the
standard appeared to be required/applicable, while certification was
not required.
Multiple comments recommended that FDA either: (1) revise or keep
the original language of certain paragraphs in Sec. 1040.10, with
removal or modifications to specific sections for clarity or (2) keep
the existing language in Sec. 1040.10(a) and instead modify Sec. Sec.
1002.1(c), 1010.2, and 1010.3, which would have the effect of
Sec. Sec. 1040.10 and 1040.11 still being required even if
certification, identification, and manufacturer's reports are not
required.
(Response 27) FDA agrees with the latter recommended approach (#2)
to keep the existing language in Sec. 1040.10, and instead amend Sec.
1002.1 in table 1 and Sec. 1010.2, consistent with the amendments in
the proposed rule, to clarify when and under what conditions reporting
would not need to be duplicated. In those situations, the manufacturers
would be considered distributors of certified laser products, and only
subject to the applicable distribution recordkeeping requirements under
Sec. Sec. 1002.40 and 1002.41 for the certified products (see Sec.
1002.1, table 1, fn. 9 in this final rule). Also, we are revising Sec.
1010.2 to identify the conditions under which a manufacturer could
incorporate a certified laser product without the requirement to re-
certify or re-report the product (see Sec. 1010.2(e) of this final
rule).
(Comment 28) Some comments raised concerns that the proposed
language in Sec. 1040.10(a)(2) did not clearly require products to
comply with the performance standards after a certified laser was
incorporated.
(Response 28) The intent of the modifications in the proposed rule
was to avoid duplicative reporting of information from manufacturers
who incorporate a certified laser system into a product. The certified
laser system, and the product into which it is incorporated, would
still be required to conform with the performance standards. Products
that incorporate a certified laser product are still required to comply
with the FDA's performance standards. To clarify this, we are revising
Sec. 1010.2 to clearly identify under what conditions a product that
incorporates a certified laser system would be considered certified,
and thus not need to be re-certified. In this final rule, all of the
following conditions must be met: (1) the incorporated laser system is
not a laser product intended for use as a component or replacement as
described in Sec. 1040.10(a)(1) and (2); (2) the manufacturer of the
incorporated laser system certifies such laser system and meets the
reporting requirements under Sec. 1002; (3) the product incorporating
the certified laser system is not independently subject to additional
reporting or performance standards requirements; (4) the incorporated
laser system is not modified as defined in Sec. 1040.10(i), and all
performance features that apply to the incorporated laser system under
Sec. 1040.10(f) are available on the product incorporating the
certified laser system; (5) all labeling requirements that apply to the
incorporated laser system under Sec. Sec. 1010.2, 1010.3, 1040.10(g),
and 1040.11(a)(3) are visible on the outside of the product
incorporating the certified laser system, with the exception that the
certification or identification labels need not be visible on the
outside of products incorporating a certified Class I laser; (6) the
incorporated laser system is installed in the product in accordance
with the instructions provided by the manufacturer of the incorporated
laser system, including instructions for placing additional externally
facing labels found in subsection (v), and meeting the other conditions
in the subsections; (7) the manufacturer of the product that
incorporates the laser system provides the end user with information
required under Sec. 1040.10(h)(1) as provided to them by the
manufacturer of the incorporated laser system; and (8) the labeling
requirements under part 1010 and Sec. 1040.10(g) for the incorporated
laser system would be met in any service configuration of the product
incorporating the laser system or when the incorporated laser system is
removed from the product into which it has been incorporated, and
reproductions of such labels are found in the user information.
Manufacturers of products that do not meet these conditions would need
to certify and report the product that incorporates the certified laser
system based on the class of the laser product as described in Sec.
1002.1.
(Comment 29) One comment raised concerns regarding the criteria for
the incorporated laser system to be installed in accordance with the
instructions provided by the manufacturer of the incorporated laser
system. The comment stated that it would be difficult for the
manufacturer of the incorporated laser system to foresee all potential
installation options by other manufacturers.
(Response 29) FDA does not expect the manufacturer of an
incorporated laser system to foresee all potential installation
options. FDA expects that a manufacturer planning to market a laser
product specifically to be certified and incorporated into other
systems would identify and specify any installation options and
requirements, while taking into consideration how reasonable variations
in the installation instructions should be provided to customers to
ensure the conditions in Sec. 1010.2(e) are met. However, ultimately,
the manufacturer of the incorporated laser system is responsible for
ensuring their finished product is in compliance with all applicable
regulatory requirements when certified and marketed. The manufacturer
of the product incorporating the laser system is responsible for
complying with the conditions in Sec. 1010.2(e). Otherwise, those
manufacturers would need to complete the certification, reporting, and
other applicable laser product requirements under Sec. Sec. 1002 and
1040.10. For example, if the installation instructions would result in
the laser product not meeting the conditions under Sec. 1010.2(e)
(e.g., instructions that would result in a required safety interlock
being unavailable), then the product incorporating the certified laser
would not be considered to have met the certification requirements
because all conditions in Sec. 1010.2(e) must be met.
(Comment 30) FDA received comments expressing concern with the
incorporation into regulation the policies described in FDA's Laser
Notice 42, including expansion of those policies into regulation for
higher
[[Page 3646]]
powered laser products without the requirements that the products
incorporating higher power lasers comply with the performance
standards. A commenter questioned whether the reporting requirements
and performance standard would be applicable to a product that
incorporated a certified Class I laser along with an uncertified Class
IV laser, and if the labeling or safety features of the final product
would need to meet the Class IV performance standards. Similar comments
recommended that FDA revise and extend policies of Laser Notice 42 for
clarity with additional requirements to ensure safety of higher class
products.
(Response 30) As noted in Response 28, this final rule is revising
Sec. 1010.2 to identify under what conditions a product that
incorporates a certified laser system would be considered to have met
the certification requirements. There are several conditions, all of
which must be met, including that the product incorporating the
certified laser system must not be independently subject to additional
reporting requirements or performance standards (see Sec.
1010.2(e)(iii) in this final rule). FDA added this clarification to the
revisions under Sec. 1010.2(e) of this final rule to ensure higher
class products will continue to be subject to any applicable
certification requirements, despite the incorporated laser system
having met the certification requirements. For example, a Class IV
laser product that incorporates a certified Class I laser does not meet
the conditions in Sec. 1010.2(e)(iii), as additional certification and
reporting requirements associated with the Class IV laser still apply.
In addition, the incorporated laser system must not be modified, as
defined in Sec. 1040.10(i), and all performance features that apply to
the incorporated laser system under Sec. 1040.10(f) must be available
on the product incorporating the certified laser system (see Sec.
1010.2(e)(iv) in this final rule). All labeling requirements that apply
to the incorporated laser system under Sec. 1040.10(g) must be visible
on the outside of the product incorporating the certified laser system,
with the exception that the certification or identification labels need
not be visible on the outside of products that incorporate a certified
Class I laser (see Sec. 1010.2(e)(v) in this final rule). The
incorporated laser system must be installed in accordance with the
instructions provided by the manufacturer of the incorporated laser
system, including ensuring any required safety features or labeling are
available (see Sec. 1010.2(e)(vi) in this final rule). The
manufacturer of the product incorporating the laser system must also
provide the end user with laser safety information as provided to them
by the manufacturer of the incorporated laser system (see Sec.
1010.2(e)(vii) in this final rule). In addition, the labeling
requirements in part 1010 and Sec. 1040.10(g) for the incorporated
laser system must be met in any service configuration of the product
that incorporates the laser system, including when the incorporated
laser system is removed from the product into which it has been
incorporated, and reproductions of such labels must be included in the
user information (see Sec. 1010.2(e)(viii) in this final rule).
(Comment 31) One comment recommended limiting the amendments only
to the lowest class of laser products; or a subset of classes with
additional clarification to address the visibility of the warning logo
type and aperture label; or all classes with clarifications about the
difference between ``attaching'' versus ``assembling in, embedding in,
or otherwise incorporating'' a laser or laser system.
(Response 31) FDA believes that the revisions to Sec. Sec. 1002.1
and 1010.2(e) that are being made in this final rule make it
sufficiently clear that the manufacturer of the product incorporating
the certified laser must not make modifications that would alter the
availability of safety information or compliance with the standard if
they wish to maintain the certification. FDA has added clarification to
the revisions under Sec. 1010.2(e)(v) and (vi) of this final rule to
ensure that visibility of certain labeling requirements that apply to
the incorporated laser system continue to be maintained. Any
modifications that would modify the class of laser, compliance with the
performance standard, visibility of required labeling, or accessibility
to required safety information would not meet the conditions of Sec.
1010.2(e) and the product would no longer be considered certified--
meaning the manufacturer of the product incorporating the laser would
need to complete the applicable certification and reporting
requirements (see also Response 29).
VI. Effective Date
This rule is effective 30 days after the date of publication in the
Federal Register.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order (E.O.) 12866, E.O. 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). EOs 12866 and 13563 direct us to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
final rule is not a significant regulatory action as defined by E.O.
12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This rule will reduce regulations that are outdated and
otherwise clarify existing requirements. Because this final rule does
not impose any additional regulatory burdens, we certify that this
final rule will not have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $165
million, using the most current (2021) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
B. Summary of Costs and Benefits
We estimate the benefits of this rule in terms of cost savings. We
derive the cost savings to industry from the reduction in labor
associated with the reporting, recordkeeping, performance standards,
and third-party disclosure requirements. Similarly, cost savings to FDA
result from the reduction in labor hours required to review reports.
The total present-value cost savings over a 20-year time period are
$69.71 million at a 7 percent discount rate and $97.89 million at a 3
percent discount rate. Annualized total cost savings are $6.58 million.
We estimate the costs to read the rule for all reporting respondents.
The present value costs are $1.60 million, and the annualized costs
calculated over a 20-year time period are $0.14 million at a 7 percent
discount rate and $0.10 million at a 3 percent
[[Page 3647]]
discount rate. A summary of the quantified cost savings and costs of
the rule are presented in Table 1.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary ------------------------------------------------
Category estimate Low estimate High estimate Discount rate Period Notes
Year dollars (percent) covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/ $6.58 $6.58 $6.58 2021 7 20 ....................
year. 6.58 6.58 6.58 2021 3 20
Annualized Quantified......... .............. .............. .............. .............. 7 .............. ....................
3
Qualitative................... .............. .............. .............. .............. .............. .............. ....................
Costs:
Annualized Monetized $millions/ 0.14 0.14 0.14 2021 7 20 ....................
year. 0.10 0.10 0.10 2021 3 20
Annualized Quantified......... .............. .............. .............. .............. 7 .............. ....................
3
Qualitative................... .............. .............. .............. .............. .............. .............. ....................
Transfers:
Federal Annualized Monetized .............. .............. .............. .............. 7 .............. ....................
$millions/year. 3
---------------------------------------------------------------------------------------------------------------------
From/To....................... From:
To:
---------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .............. .............. .............. .............. 7 .............. ....................
$millions/year. 3
---------------------------------------------------------------------------------------------------------------------
From/To....................... From:
To:
---------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business:.....................................................................................................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Summary of Regulatory Flexibility Analysis
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the rule does not impose any additional
regulatory burdens, we certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
This analysis, as well as other sections in this document and the
Preamble of the final rule, serves as the Final Regulatory Flexibility
Analysis, as required under the Regulatory Flexibility Act. The full
preliminary analysis of economic impacts is available in the docket for
this final rule (Ref. 18) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VIII. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) and (i) and
25.34(c) that this action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting, recordkeeping, and third-party
disclosure burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
Title: Electronic Products; OMB Control No. 0910-0025--Revision
Description: FDA is amending its regulations for requirements for
certain reporting and records of electronic products by removing
specific reporting, as well as repealing outdated recommendations for
radiation protection and performance standards, and removing submission
requirements for copies of certain applications and forms to alleviate
regulatory burden to both FDA and industry.
The records and reporting requirements for electronic products and
medical devices include various reports and records depending upon the
specific type of electronic product. FDA has determined upon review of
the records and reporting requirements that some of the requirements
are unnecessary or may be duplicative of other reporting requirements
by FDA and State regulators.
Description of Respondents: The respondents to this information
collection are electronic product manufacturers, importers, and
assemblers of electronic products from private sector, for-profit
businesses.
[[Page 3648]]
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
Activity; 21 CFR section FDA form Number of responses per Total annual Average burden per hours
respondents respondent responses response \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k) \3\.... 3639--Cabinet x-ray....... 1,149 2.2 2,529 24....................... 60,685
3632--Laser...............
3640--Laser light show....
3630--Sunlamp.............
3659--TV..................
3660--Microwave oven......
3801--UV lamps............
Supplemental reports--1002.11(a)-(b) .......................... 440 2.5 1,100 0.5 (30 minutes)......... 550
\3\.
Abbreviated reports--1002.12 \3\....... 3629--General abbreviated 54 1.8 97 5........................ 485
report.
3646--Mercury Vapor Lamp
Products Radiation Safety
Report.
3663--Microwave products
(non-oven).
Annual reports--1002.13(a)-(b) \3\..... 3628--General............. 1,410 1.3 1,833 18....................... 32,994
3634--TV..................
3641--Cabinet x-ray.......
3643--Microwave oven......
3636--Laser...............
3631--Sunlamp.............
Accidental radiation occurrence 3649--ARO................. 75 4 300 2........................ 600
reports--1002.20 \3\.
Exemption requests--1002.50(a) and 3642--General 4 1.3 5 1........................ 5
1002.51 \4\. correspondence.
Product and sample information--1005.10 2767--Sample product...... 5 1 5 0.1 (6 minutes).......... 1
\4\.
Identification information and 2877--Imports declaration. 12,620 2.5 31,550 0.2 (12 minutes)......... 6,310
compliance status--1005.25 \4\.
Alternate means of certification-- .......................... 1 2 2 5........................ 10
1010.2(d) \4\.
Variance--1010.4(b) \4\................ 3633--General variance 350 1.1 385 1.2...................... 462
request.
3147--Laser show variance
request.
3635--Laser show
notification.
Exemption from performance standards-- .......................... 1 1 1 22....................... 22
1010.5(c) and (d) \4\.
Alternate test procedures--1010.13 \4\. .......................... 1 1 1 10....................... 10
Microwave oven exemption from warning .......................... 1 1 1 1........................ 1
labels--1030.10(c)(6)(iv) \4\.
Laser products registration-- 3637--Original equipment 70 2.9 203 3........................ 609
1040.10(a)(3)(i) \4\. manufacturer (OEM) report.
------------------------------------------------------------------------------------
Total.............................. .......................... .............. .............. .............. ......................... 102,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.
\3\ We have requested revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience of the reader. We have not requested
revision of this line item at this time.
Table 3--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping \2\
----------------------------------------------------------------------------------------------------------------
Manufacturer test and 1,409 1,650 2,324,850 0.12 (7 minutes) 278,982
distribution records--
1002.30 and 1002.31(a) \3\.
Dealer/distributor records-- 2,909 50 145,450 0.05 (3 minutes) 7,273
1002.40 and 1002.41 \3\.
Information on diagnostic x- 50 1 50 0.5 (30 minutes) 25
ray systems--1020.30(g) \4\.
[[Page 3649]]
Laser products distribution 70 1 70 1............... 70
records-- 1040.10(a)(3)(ii)
\4\.
----------------------------------------------------------------------------------
Total.................... ............... .............. .............. ................ 286,350
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours have been rounded.
\3\ We have requested revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience
of the reader. We have not requested revision of this line item at this time.
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety 1 1 1 12 12
information for users--
1002.3 \3\.................
Dealer/distributor records-- 30 3 90 1 90
1002.40 and 1002.41 \3\....
Television receiver critical 1 1 1 1 1
component warning--
1020.10(c)(4) \3\..........
Cold cathode tubes-- 1 1 1 1 1
1020.20(c)(4) \3\..........
Report of assembly of 1,230 34 41,820 0.3 (18 minutes) 12,546
diagnostic x-ray
components--...............
1020.30(d), (d)(1)-(2) (Form
FDA 2579--Assembler report)
\4\........................
Information on diagnostic x- 6 1 6 55 330
ray systems--1020.30(g) \3\
Statement of maximum line 6 1 6 10 60
current of x-ray systems--
1020.30(g)(2) \3\..........
Diagnostic x-ray system 6 1 6 200 1,200
safety and technical
information--1020.30(h)(1)-
(4) \3\....................
Fluoroscopic x-ray system 5 1 5 25 125
safety and technical
information--1020.30(h)(5)-
(6) and 1020.32(a)(1), (g),
and (j)(4) \3\.............
CT equipment--1020.33(c)- 5 1 5 150 750
(d), (g)(4), and (j) \3\...
Cabinet x-ray systems 6 1 6 40 240
information--1020.40(c)(9)(
i)-(ii) \3\................
Microwave oven radiation 1 1 1 20 20
safety instructions--
1030.10(c)(4) \3\..........
Microwave oven safety 1 1 1 20 20
information and
instructions--1030.10(c)(5)
(i)-(iv) \3\...............
Microwave oven warning 1 1 1 1 1
labels--1030.10(c)(6)(iii)
\3\........................
Laser products information-- 2 1 2 20 40
1040.10(h)(1)(i)-(vi) \4\..
Laser product service 2 1 2 20 40
information--1040.10(h)(2)(
i)-(ii) \4\................
Medical laser product 2 1 2 10 20
instructions--1040.11(a)(2)
\3\........................
Sunlamp products 1 1 1 10 10
instructions--1040.20 \3\..
Mercury vapor lamp labeling-- 1 1 1 1 1
1040.30(c)(1)(ii) \3\......
Mercury vapor lamp 1 1 1 1 1
permanently affixed labels--
1040.30(c)(2) \3\..........
-----------------------------------------------------------------------------------
Total................... ............... .............. .............. ................. 15,508
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours have been rounded.
\3\ The burden estimate for this information collection is currently approved and included for the convenience
of the reader. We have not requested revision of this line item at this time.
\4\ We have requested revision of this information collection.
The estimates were generated from discussions with subject matter
experts at FDA.
FDA is revising the applicability of the recordkeeping and
reporting requirements for some products (Sec. 1002.1). We revised the
burden estimates for product reports, supplemental reports, abbreviated
reports, annual reports, manufacturer test and distribution records,
and dealer and distributor records by reducing the number of
respondents/recordkeepers to reflect the revised applicability of the
recordkeeping and reporting requirements. We also revised Form FDA 3646
``Mercury Vapor Lamp Products Radiation Safety Report'' (now listed
under Abbreviated Reports consistent with the revision of Sec. 1002.1)
and removed the following forms:
Form FDA 3626, ``A Guide for the Submission of Initial Reports
on Diagnostic X-Ray Systems and Their Major Components''
Form FDA 3627, ``Diagnostic X-Ray CT Products Radiation Safety
Report''
[[Page 3650]]
Form FDA 3638, ``Guide for Filing Annual Reports for X-Ray
Components and Systems,''
Form FDA 3644, ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
Form FDA 3645, ``Guidance for Preparing Annual Reports for
Ultrasonic Therapy Products,''
Form FDA 3647, ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
Form FDA 3661, ``Guide for the Submission of an Abbreviated
Report on X-ray Tables, Cradles, Film Changers or Cassette Holders
Intended for Diagnostic Use''
Form FDA 3662, ``Guide for Submission of an Abbreviated
Radiation Safety Reports on Cephalometric Devices Intended for
Diagnostic Use''
The amended applicability of the recordkeeping requirements for
dealer and distributor records (see Sec. Sec. 1002.40 and 1002.41)
results in a small decrease in the number of recordkeepers.
FDA is eliminating requirements for manufacturers to report model
numbers of new models of a model family that do not involve changes in
radiation emission or requirements of a performance standard in
quarterly updates to their annual reporting (Sec. 1002.13(c)). We have
removed the burden estimate associated with Sec. 1002.13(c).
Generally, other subsections require specified product manufacturers to
submit annual reports to FDA which summarize certain manufacturing
records (Sec. 1002.13(a) and (b)). FDA is not amending these annual
report requirements.
FDA is amending the timing for submission of reporting requirements
for AROs that are not associated with a death or serious injury (Sec.
1002.20). The amendment will allow manufacturers of a radiation
emitting electronic product to submit quarterly summary reports of AROs
that are not associated with a death or serious injury and not required
to be reported under the medical device reporting regulations (Sec.
1002.20; part 803). FDA believes that amending the regulations to allow
summary reporting for AROs for electronic products extends the approach
of eliminating or reducing duplicative reporting requirements beyond
the medical device arena and promotes harmonization between this
reporting and the new voluntary malfunction summary reporting for
medical devices (see part 803; ``Medical Devices and Device-Led
Combination Products; Voluntary Malfunction Summary Reporting Program
for Manufacturers'' (83 FR 40973, August 17, 2018)).
FDA is also amending the applications for variances process (Sec.
1010.4(b)) to no longer require a manufacturer to submit two additional
copies with the original documents. While this amendment would not
generate any substantive change to the information collection,
respondents may realize a small monetary savings from the usual and
customary administrative expenses associated with the preparation of
the copies.
FDA is amending the reports of assembly requirements for major
components of diagnostic x-ray systems to no longer require assemblers
who install certified components to submit a report of assemblies, Form
FDA 2579, to CDRH (Sec. 1020.30(d)(1)). FDA is also withdrawing the
language that requires submission to ``the Director'' in this
subsection, but will still publish a PDF form online for assemblers to
download, complete, and provide to applicable States and purchasers as
required. We have moved the corresponding information collection burden
estimate from reporting to third-party disclosure burden and revised
Form FDA 2579.
FDA is amending the reporting requirements for manufacturers that
incorporate a certified laser product to reduce reporting that is
considered duplicative under certain conditions. Manufacturers that
incorporate a certified laser system meeting the conditions of Sec.
1010.2(e) are considered distributors of the certified laser and only
subject to the applicable distribution recordkeeping requirements under
Sec. Sec. 1002.40 and 1002.41 for the certified products. Accordingly,
we have reduced the number of respondents for ``Laser products
information--1040.10(h)(1)(i)-(vi)'' and ``Laser product service
information--1040.11(h)(2)(i)-(ii).''
FDA is repealing the performance standards for ultrasonic therapy
products (Sec. 1050.10). We have therefore removed the burden estimate
associated with Sec. 1050.10.
We received several comments related to the proposed rule.
Descriptions of the comments and our responses are provided in Section
V of this document, Comments on the Proposed Rule and FDA Response.
Comments and responses related to the provisions that underlie the
information collection are described in the following sections: section
V.B, regarding general comments; section V.E, regarding records and
reports; section V.F, regarding reports of assembly, forms and
guidances; section V.G, regarding accidental radiation occurrences; and
section V.H, regarding laser comments. We have not made changes to the
estimated burden as a result of the comments.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in E.O. 13132. We have determined that this rule does not
contain policies that have substantial direct effects on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. Accordingly, we conclude that the rule does not contain
policies that have federalism implications as defined in the E.O. and,
consequently, a federalism summary impact statement is not required.
We note that the current performance standards at Sec. 1040.10
issued under section 534 of the FD&C Act preempt the States from
establishing or continuing in effect any standard that is not identical
to the Federal standard pursuant to section 542 of the FD&C Act. Those
standards were issued before the E.O. We believe this preemption is
consistent with section 4(a) of the E.O. which requires agencies to
``construe . . . a Federal statute to preempt State law only where the
statute contains an express preemption provision or there is some other
clear evidence that the Congress intended preemption of State law, or
where the exercise of State authority conflicts with the exercise of
Federal authority under the Federal statute.'' Federal law includes an
express preemption provision at section 542 of the FD&C Act that
preempts the States from establishing, or continuing in effect, any
standard with respect to an electronic product which is applicable to
the same aspect of product performance as a Federal standard prescribed
pursuant to section 534 of the FD&C Act and which is not identical to
the Federal standard. (See Medtronic, Inc. v. Lohr, 518 U.S. 470
(1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). Section 542 of
the FD&C Act does allow States to impose a more restrictive standard
regarding emissions of
[[Page 3651]]
radiation from electronic products under certain circumstances.
This final rule does not impose any new performance standard
requirements. This rule prescribes a reduction in Federal standards
(through repeal of Sec. 1050.10) pursuant to section 534 of the FD&C
Act. This rule removes or excludes applicability of certain Federal
standards, which no longer preempt any State issued performance
standards to that same extent.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this final rule in accordance with the principles
set forth in E.O. 13175. We have determined that the rule does not
contain policies that would have a substantial direct effect on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. They also can be purchased as a pdf or as
hard copy (or both together, at a discounted price) from NCRP
(www.ncrponline.org). FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
*1. EPA, Interagency Working Group on Medical Radiation, Federal
Guidance Report No. 14. ``Radiation Protection Guidance for
Diagnostic and Interventional X-Ray Procedures,'' 2014, available at
https://www.epa.gov/sites/production/files/2015-05/documents/fgr14-2014.pdf.
2. NCRP, ``Radiation Dose Management for Fluoroscopically-Guided
Interventional Procedures,'' Report No. 168, 2010, available at
https://ncrponline.org/publications/reports/ncrp-report-168/.
*3. FDA, CDRH Health, ``Initiative to Reduce Unnecessary Radiation
Exposure from Medical Imaging'' (2010), available at https://
www.fda.gov/radiation-emitting-products/initiative-reduce-
unnecessary-radiation-exposure-medical-imaging/white-paper-
initiative-reduce-unnecessary-radiation-exposure-medical-
imaging#:~:text=practicing%20medical%20community.-
,Initiative%20to%20Reduce%20Unnecessary%20Radiation%20Exposure%20from
%20Medical%20Imaging,CT%2C%20fluoroscopy%2C%20and%20nuclear%20medicin
e.
*4. FDA, ``Medical X-ray Imaging,'' available at https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm.
*5. 2016 TEPRSSC Meeting, October 25-26, 2016, available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/ucm526004.htm.
6. NCRP, ``Radiation Protection in Dentistry,'' Report No. 145,
2003, available at https://ncrponline.org/publications/reports/ncrp-reports-145/.
*7. American Dental Association and FDA, ``Dental Radiographic
Examinations: Recommendations for Patient Selection and Limiting
Radiation Exposure,'' revised: 2012, available at https://www.fda.gov/media/84818/download.
*8. The American College of Radiology publishes and regularly
updates Practice Parameters, Technical Standards, and
Appropriateness Criteria[supreg], available at https://www.acr.org/Quality-Safety/Appropriateness-Criteria.
*9. ICRP, ``The 2007 Recommendations of the International Commission
on Radiological Protection. ICRP publication 103.'' Annals of the
ICRP. 2007;37(2-4):1-332, available at https://www.icrp.org/publication.asp?id=ICRP%20Publication%20103.
10. Nationwide Evaluation of X-Ray Trends (NEXT), ``Tabulation and
Graphical Summary of the 2014-2015 Dental Survey.'' February 2019.
CRCPD Publication-E-16-2, available at https://cdn.ymaws.com/www.crcpd.org/resource/collection/81C6DB13-25B1-4118-8600-9615624818AA/E-19-2_2014-2015_Dental_NEXT_Summary_Report.pdf.
11. NCRP, ``Radiation Protection in Dentistry and Oral and
Maxillofacial Imaging. Report No. 177,'' 2019, available at https://ncrponline.org/shop/reports/report-no-177/.
*12. OMB directive Circular A-119, ``Federal Participation in the
Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities,'' available at https://www.federalregister.gov/documents/2016/01/27/2016-01606/revision-of-omb-circular-no-a-119-federal-participation-in-the-development-and-use-of-voluntary.
*13. FDA, ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program,'' May 7, 2019, available at
https://www.fda.gov/media/114034/download.
14. IEC 60417:2002 DB, ``Graphical Symbols for Use on Equipment,''
available at https://webstore.iec.ch/publication/2098.
*15. FDA, Import Program, available at https://www.fda.gov/industry/import-program-food-and-drug-administration-fda.
*16. FDA, ``Medical X-Ray Imaging Devices Conformance with IEC
Standards,'' May 8, 2019, available at https://www.fda.gov/media/99466/download.
17. NCRP, ``Management of Exposure to Ionizing Radiation: Radiation
Protection Guidance for the United States. Report No. 180,'' 2018,
available at https://ncrponline.org/shop/reports/report-no-180-management-of-exposure-to-ionizing-radiation-radiation-protection-guidance-for-the-united-states-2018-2018/.
*18. Economic Analysis of Impacts: Radiological Health Regulations;
Amendments to Records and Reports for Radiation Emitting Electronic
Products; Amendments to Performance Standards for Diagnostic X-ray,
Laser and Ultrasonic Products, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
List of Subjects
21 CFR Parts 1000 and 1002
Electronic products, Radiation protection, Reporting and
recordkeeping requirements, X-rays.
21 CFR Part 1010
Administrative practice and procedure, Electronic products,
Exports, Radiation protection.
21 CFR Part 1020
Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.
21 CFR Part 1030
Electronic products, Microwave ovens, Radiation protection.
21 CFR Part 1050
Electronic products, Medical devices, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1000, 1002, 1010, 1020, 1030, and 1050 are amended as follows:
[[Page 3652]]
PART 1000--GENERAL
0
1. The authority citation for part 1000 continues to read as follows:
Authority: 21 U.S.C. 360hh-360ss.
0
2. Amend Sec. 1000.3 by revising paragraph (a) and removing paragraph
(s) and redesignating paragraphs (t) and (u) as paragraphs (s) and (t).
The revision reads as follows:
Sec. 1000.3 Definitions.
* * * * *
(a) Accidental radiation occurrence means a single accidental event
or series of accidental events that has/have resulted in injurious or
potentially injurious exposure of any person to electronic product
radiation as a result of the manufacturing, testing, or use of an
electronic product.
* * * * *
Subpart C--[Removed]
0
3. Remove subpart C, consisting of Sec. Sec. 1000.50, 1000.55, and
1000.60.
PART 1002--RECORDS AND REPORTS
0
4. The authority citation for part 1002 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.
0
5. Amend Sec. 1002.1 by revising table 1 to read as follows:
* * * * *
Table 1 to Sec. 1002.1--Record and Reporting Requirements by Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturer Dealer &
---------------------------------------------------------------------------------------------------------------------------------------- distributor
Test Distribution ----------------
Product Supplemental Abbreviated Annual reports records records Distribution
Products reports reports reports 1002.12 1002.13 1002.30(a) 1002.30(b) records 1002.40
1002.10 1002.11 \1\ \2\ and 1002.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY \3\ (1020.30, 1020.31, 1020.32,
1020.33):
Computed tomography............................ .......... ............ ............... ............... X X X
X-ray system \4\............................... .......... ............ ............... ............... X X X
Tube housing assembly.......................... .......... ............ ............... ............... X X ...............
X-ray control.................................. .......... ............ ............... ............... X X X
X-ray high voltage generator................... .......... ............ ............... ............... X X X
X-ray table or cradle.......................... .......... ............ ............... ............... X X X
X-ray film changer............................. .......... ............ ............... ............... X X ...............
Vertical cassette holders mounted in a fixed .......... ............ ............... ............... X X X
location and cassette holders with front
panels........................................
Beam-limiting devices.......................... .......... ............ ............... ............... X X X
Spot-film devices and image intensifiers .......... ............ ............... ............... X X X
manufactured after April 26, 1977.............
Cephalometric devices manufactured after .......... ............ ............... ............... X X ...............
February 25, 1978.............................
Image receptor support devices for mammographic .......... ............ ............... ............... X X X
X-ray systems manufactured after September 5,
1978..........................................
CABINET X RAY (1020.40):
Baggage inspection............................. X X ............... X X X X
Other.......................................... X X ............... X X X ...............
PRODUCTS INTENDED TO PRODUCE PARTICULATE
RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR
CABINET X-RAY:
Medical........................................ .......... ............ ............... ............... X X ...............
Analytical..................................... .......... ............ X X X X ...............
Industrial..................................... .......... ............ X X X X ...............
TELEVISION PRODUCTS (1020.10):
<0.1 milliroentgen per hour (mR/hr) IRLC \5\... .......... ............ X \8\ X \6\ .......... ............ ...............
>=0.1mR/hr IRLC \5\............................ X \8\ ............ ............... X X X ...............
MICROWAVE/RF:
MW ovens (1030.10)............................. X \8\ ............ ............... X X X ...............
MW diathermy................................... .......... ............ X ............... .......... ............ ...............
MW heating, drying, security systems........... .......... ............ X ............... .......... ............ ...............
RF sealers, electromagnetic induction and .......... ............ X ............... .......... ............ ...............
heating equipment, dielectric heaters (2-500
megahertz)....................................
OPTICAL:
Laser products (1040.10, 1040.11).............. .......... ............ ............... ............... .......... ............ ...............
Class I lasers and products containing such X \8\ ............ ............... X X ............ ...............
lasers \7 9\..................................
Class I laser products containing class IIa, X ............ ............... X X X ...............
II, IIIa, lasers \7 9\........................
Class IIa, II, IIIa lasers and products other X ............ ............... X X X X
than class I products containing such lasers
\7 9\.........................................
Class IIIb and IV lasers and products X X ............... X X X X
containing such lasers \7\....................
SUNLAMP PRODUCTS (1040.20):
Lamps only..................................... X ............ ............... ............... .......... ............ ...............
Sunlamp products............................... X X ............... X X X X
Mercury vapor lamps (1040.30).................. .......... ............ ............... ............... .......... ............ ...............
R lamps and T lamps............................ .......... ............ X ............... .......... ............ ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\ The requirement includes Sec. Sec. 1002.31 and 1002.42, if applicable.
\3\ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see Sec. 1020.30(d)(1)-(3) of this chapter.
\4\ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in Sec. 1020.30(c) of this
chapter.
\5\ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (Sec. 1020.10(c)(3)(iii)) of this chapter.
\6\ Annual report is for production status information only.
\7\ Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
[[Page 3653]]
\8\ Manufacturers are exempt from product reports (Sec. 1002.10) and abbreviated reports (Sec. 1002.12), except the first product or abbreviated
report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance,
service, or failure (e.g., Class I optical disc products, laser printers).
\9\ Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified
laser and only subject to the applicable distribution recordkeeping requirements under Sec. Sec. 1002.40 and 1002.41 for the certified products.
Sec. 1002.13 [Amended]
0
6. Amend Sec. 1002.13 by removing paragraph (c).
0
7. Revise Sec. 1002.20 to read as follows:
Sec. 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable
grounds for suspecting that such an incident has occurred, report to
the Director, Center for Devices and Radiological Health, all
accidental radiation occurrences reported to or otherwise known to the
manufacturer and arising from the manufacturing, testing, or use of any
product introduced or intended to be introduced into commerce by such
manufacturer. Reasonable grounds include, but are not necessarily
limited to, professional, scientific, or medical facts or opinions
documented or otherwise, that conclude or lead to the conclusion that
such an incident has occurred.
(b) Such reports shall be submitted either electronically through
Center for Devices and Radiological Health eSubmitter or addressed to
the Food and Drug Administration, Center for Devices and Radiological
Health, ATTN: Accidental Radiation Occurrence Reports, Document Mail
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD
20993-0002, and the reports and their envelopes shall be distinctly
marked ``Report on 1002.20'' and shall contain all of the following
information where known to the manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence
occurred;
(3) The manufacturer, type, and model number of the electronic
product or products involved;
(4) The circumstances surrounding the accidental radiation
occurrence, including causes;
(5) The number of persons involved, adversely affected, or exposed
during the accidental radiation occurrence, the nature and magnitude of
their exposure and/or injuries and, if requested by the Director,
Center for Devices and Radiological Health, the names of the persons
involved;
(6) The actions, if any, which may have been taken by the
manufacturer, to control, correct, or eliminate the causes and to
prevent reoccurrence; and
(7) Any other pertinent information with respect to the accidental
radiation occurrence.
(c) If a manufacturer:
(1) Is required to report to the Director under paragraph (a) of
this section and also is required to report under part 803 of this
chapter, the manufacturer shall report in accordance with part 803; or
(2) Is required to report to the Director under paragraph (a) of
this section and is not required to report under part 803 of this
chapter, the manufacturer shall:
(i) Immediately report incidents associated with a death or serious
injury in accordance with paragraphs (a) and (b) of this section; and
(ii) Either immediately report incidents not associated with a
death or serious injury individually or compile such incidents for
submission in a quarterly summary report with tracking and trending
analysis of that data in accordance with paragraphs (a) and (b) of this
section. The quarterly report must cover information required under
paragraphs (b)(1) through (7) of this section for each occurrence were
known to the manufacturer. Occurrences may be grouped to identify the
most common circumstances and potential cause(s), including but not
limited to, design changes, manufacturing, or user. Planned
mitigation(s) with an assessment of effectiveness, or a justification
for why mitigation is not necessary, must be associated with each
occurrence or grouping of similar occurrences. A manufacturer need not
file a separate report under this section if an incident involving an
accidental radiation occurrence is associated with a defect or
noncompliance and is reported pursuant to Sec. 1003.10 of this
chapter.
PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
0
8. The authority citation for part 1010 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.
0
9. Amend Sec. 1010.2 by adding paragraph (e) to read as follows:
Sec. 1010.2 Certification.
* * * * *
(e) Laser products under Sec. 1040.10 of this chapter that
incorporate a certified laser system (laser product) will be considered
to have met the certification requirements in this section if all of
the following conditions are met:
(1) The incorporated laser system is not a laser product intended
for use as a component or replacement as described in Sec.
1040.10(a)(1) and (2) of this chapter;
(2) The manufacturer of the incorporated laser system has certified
such laser system under this section and meets the reporting
requirements under part 1002 of this chapter;
(3) The product incorporating the certified laser system is not
independently subject to additional reporting or performance standards
requirements;
(4) The incorporated laser system is not modified as defined in
Sec. 1040.10(i) of this chapter, and all performance features that
apply to the incorporated laser system under Sec. 1040.10(f) are
available on the product incorporating the certified laser system;
(5) All labeling requirements that apply to the incorporated laser
system under Sec. Sec. 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3)
of this chapter are visible on the outside of the product incorporating
the certified laser system, with the exception that the certification
or identification labels need not be visible on the outside of products
incorporating a certified Class I laser;
(6) The incorporated laser system is installed in accordance with
the instructions provided by the manufacturer of the incorporated laser
system, including instructions for placing additional externally facing
labels found in paragraph (e)(5) of this section, and meeting the other
conditions in paragraphs (e)(1) through (8) of this section;
(7) The manufacturer of the product that incorporates the laser
system provides the end user with information required under Sec.
1040.10(h)(1) of this chapter as provided to them by the manufacturer
of the incorporated laser system; and
(8) The labeling requirements under part 1010 and Sec. 1040.10(g)
of this chapter for the incorporated laser system would be met in any
service configuration of the product incorporating the laser system or
when the incorporated laser system is removed from the product into
which it had been incorporated, and reproductions of such labels are
found in the user information.
[[Page 3654]]
0
10. Amend Sec. 1010.3 by revising paragraph (a)(2)(ii) to read as
follows:
Sec. 1010.3 Identification.
* * * * *
(a) * * *
(2) * * *
(ii) The month and year of manufacture shall be provided clearly
and legibly, without abbreviation, and with the year shown as a four-
digit number as follows in this paragraph. Alternatively, a
manufacturer may utilize a manufacturing symbol and date format that
conforms with an applicable FDA recognized consensus standard.
Manufactured: (Insert Month and Year of Manufacture.)
* * * * *
0
11. Amend Sec. 1010.4 by revising paragraphs (b) introductory text,
(b)(1), and (b)(2) introductory text to read as follows:
Sec. 1010.4 Variances.
* * * * *
(b) Applications for variances. If you are submitting an
application for variances or for amendments or extensions thereof:
(1) You must either:
(i) Submit the variance application and supporting materials to
CDRH by email using the [email protected] mailbox;
or
(ii) Submit an original copy of the variance application by mail
to: U.S. Food and Drug Administration, Center for Devices and
Radiological Health, Document Mail Center, Bldg. 66, Rm. G609, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002.
(2) The application for variance shall include the following
information:
* * * * *
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS
0
12. The authority citation for part 1020 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371,
381.
0
13. Amend Sec. 1020.10 by revising paragraph (a) to read as follows:
Sec. 1020.10 Television receivers with cathode ray tubes.
(a) Applicability. The provisions of this section are applicable to
television receivers with cathode ray tubes manufactured subsequent to
January 15, 1970.
* * * * *
0
14. Amend Sec. 1020.30 by revising paragraphs (d)(1) and (d)(2)(ii) to
read as follows:
Sec. 1020.30 Diagnostic x-ray systems and their major components.
* * * * *
(d) * * *
(1) Reports of assembly. All assemblers who install certified
components shall file a report of assembly, except as specified in
paragraph (d)(2) of this section. The report will be construed as the
assembler's certification and identification under Sec. Sec. 1010.2
and 1010.3 of this chapter. The assembler shall affirm in the report
that the manufacturer's instructions were followed in the assembly or
that the certified components as assembled into the system meet all
applicable requirements of Sec. Sec. 1020.30 through 1020.33. All
assembler reports must be on a form (Form FDA 2579 made available at
https://www.fda.gov/about-fda/reports-manuals-forms/forms) prescribed
by the Director, Center for Devices and Radiological Health. Completed
reports must be submitted to the purchaser and, where applicable, to
the State agency responsible for radiation protection within 15 days
following completion of the assembly.
(2) * * *
(ii) Certified accessory components;
* * * * *
PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY
EMITTING PRODUCTS
0
15. The authority citation for part 1030 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.
0
16. Amend Sec. 1030.10 by revising paragraph (c)(6)(iv) introductory
text as follows:
Sec. 1030.10 Microwave ovens.
* * * * *
(c) * * *
(6) * * *
(iv) Upon application by a manufacturer, the Director, Center for
Devices and radiological Health, Food and Drug Administration, may
grant an exemption from one or more of the statements (radiation safety
warnings) specified in paragraph (c)(6)(i) of this section. Such
exemption shall be based upon a determination by the Director that the
microwave oven model for which the exemption is sought should continue
to comply with paragraphs (c)(1) through (3) of this section under the
adverse condition of use addressed by such precautionary statement(s).
An application shall be submitted to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Copies of the written portion of the application,
including supporting data and information, and the Director's action on
the application will be maintained by the Dockets Management Branch for
public review. The application shall include:
* * * * *
PART 1050--[REMOVED AND RESERVED]
0
17. Under the authority of 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-
360ss, 371, 381, part 1050 is removed and reserved.
Dated: January 4, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-00922 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P
