Medical Devices; Technical Amendments, 16878-16880 [2023-05657]
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16878
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Rules and Regulations
determined this action will not have a
substantial direct effect on the States, or
the relationship between the Federal
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, this
rule will not have federalism
implications.
B. Executive Order 13211, Regulations
That Significantly Affect Energy Supply,
Distribution, or Use
The FAA analyzed this rule under
Executive Order 13211. The agency has
determined it is not a ‘‘significant
energy action’’ under the executive
order and will not be likely to have a
significant adverse effect on the supply,
distribution, or use of energy.
C. Executive Order 13609, Promoting
International Regulatory Cooperation
Executive Order 13609 promotes
international regulatory cooperation to
meet shared challenges involving
health, safety, labor, security,
environmental, and other issues and to
reduce, eliminate, or prevent
unnecessary differences in regulatory
requirements. The FAA has analyzed
this action under the policies and
agency responsibilities of Executive
Order 13609 and has determined that
this action will have no effect on
international regulatory cooperation.
ddrumheller on DSK120RN23PROD with RULES1
List of Subjects in 14 CFR Part 91
Air traffic control, Aircraft, Airmen,
Airports, Aviation safety, Freight, Libya.
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends chapter I of title 14, Code of
Federal Regulations, as follows:
PART 91—GENERAL OPERATING AND
FLIGHT RULES
1. The authority citation for part 91
continues to read as follows:
A. Electronic Access
Except for classified and controlled
unclassified material not authorized for
public release, all documents the FAA
considered in developing this rule,
including economic analyses and
technical reports, may be accessed from
the internet through the docket for this
rulemaking.
Those documents may be viewed
online at https://www.regulations.gov
using the docket number listed above. A
copy of this rule will be placed in the
docket. Electronic retrieval help and
guidelines are available on the website.
It is available 24 hours each day, 365
days each year. An electronic copy of
this document may also be downloaded
from the Office of the Federal Register’s
website at https://
www.federalregister.gov and the
Government Publishing Office’s website
at https://www.govinfo.gov. A copy may
also be found at the FAA’s Regulations
and Policies website at https://
www.faa.gov/regulations_policies.
Copies may also be obtained by
sending a request to the Federal
Aviation Administration, Office of
Rulemaking, ARM–1, 800 Independence
16:41 Mar 20, 2023
B. Small Business Regulatory
Enforcement Fairness Act
The Small Business Regulatory
Enforcement Fairness Act of 1996
(SBREFA) (Pub. L. 104–121) (set forth as
a note to 5 U.S.C. 601) requires FAA to
comply with small entity requests for
information or advice about compliance
with statutes and regulations within its
jurisdiction. A small entity with
questions regarding this document may
contact its local FAA official, or the
persons listed under the FOR FURTHER
INFORMATION CONTACT heading at the
beginning of the preamble. To find out
more about SBREFA on the internet,
visit https://www.faa.gov/regulations_
policies/rulemaking/sbre_act/.
■
X. Additional Information
VerDate Sep<11>2014
Avenue SW, Washington, DC 20591, or
by calling (202) 267–9677. Commenters
must identify the docket or notice
number of this rulemaking.
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Authority: 49 U.S.C. 106(f), 106(g), 40101,
40103, 40105, 40113, 40120, 44101, 44111,
44701, 44704, 44709, 44711, 44712, 44715,
44716, 44717, 44722, 46306, 46315, 46316,
46504, 46506–46507, 47122, 47508, 47528–
47531, 47534, Pub. L. 114–190, 130 Stat. 615
(49 U.S.C. 44703 note); articles 12 and 29 of
the Convention on International Civil
Aviation (61 Stat. 1180), (126 Stat. 11).
2. Amend § 91.1603 by revising the
section heading and paragraphs (b), (c),
and (e) to read as follows:
■
§ 91.1603 Special Federal Aviation
Regulation No. 112—Prohibition Against
Certain Flights in the Territory and Airspace
of Libya.
*
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*
(b) Flight prohibition. Except as
provided in paragraphs (c) and (d) of
this section, no person described in
paragraph (a) of this section may
conduct flight operations in the territory
and airspace of Libya.
(c) Permitted operations. This section
does not prohibit persons described in
paragraph (a) of this section from
conducting flight operations in the
territory and airspace of Libya, provided
that such flight operations occur under
a contract, grant, or cooperative
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agreement with a department, agency, or
instrumentality of the U.S. Government
(or under a subcontract between the
prime contractor of the department,
agency, or instrumentality and the
person described in paragraph (a) of this
section), with the approval of the FAA,
or under an exemption issued by the
FAA. The FAA will consider requests
for approval or exemption in a timely
manner, with the order of preference
being: First, for those operations in
support of U.S. Government-sponsored
activities; second, for those operations
in support of government-sponsored
activities of a foreign country with the
support of a U.S. Government
department, agency, or instrumentality;
and third, for all other operations.
*
*
*
*
*
(e) Expiration. This SFAR will remain
in effect until March 20, 2025. The FAA
may amend, rescind, or extend this
SFAR, as necessary.
Issued in Washington, DC, under the
authority of 49 U.S.C. 106(f) and (g),
40101(d)(1), 40105(b)(1)(A), and 44701(a)(5),
on or about March 13, 2023.
Billy Nolen,
Acting Administrator.
[FR Doc. 2023–05390 Filed 3–17–23; 11:15 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 10, 803, 812, and 822
[Docket No. FDA–2021–N–0246]
Medical Devices; Technical
Amendments
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendments.
AGENCY:
The Food and Drug
Administration (FDA, the Agency, or
we) is amending certain medical device
regulations to update mailing address
and docket number and conform the
regulatory provisions to the Federal
Food, Drug, and Cosmetics Act (FD&C
Act). The rule does not impose any new
regulatory requirements on affected
parties. This action is editorial in nature
to correct errors and to ensure accuracy
and clarity in the Agency’s regulations.
DATES: This rule is effective March 21,
2023.
FOR FURTHER INFORMATION CONTACT:
Madhusoodana Nambiar, Office of
Policy, Center for Devices and
SUMMARY:
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Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Rules and Regulations
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993–0002, 301–
796–5837.
SUPPLEMENTARY INFORMATION:
I. Background
As a part of this technical
amendment, the FDA Center for Devices
and Radiological Health (CDRH) is
making changes to 21 CFR parts 10, 803,
812, and 822 to revise contact addresses,
correct docket numbers, and conform
the regulatory provisions to the FD&C
Act to ensure accuracy and clarity in the
Agency’s medical device regulations.
The changes published in this notice are
non-substantive and editorial in nature.
ddrumheller on DSK120RN23PROD with RULES1
II. Description of the Technical
Amendments
The regulation, 21 CFR 10.80(h), is
being revised to make a non-substantive
editorial change to update a citation that
was moved from title 42 to title 21. In
§ 803.19(b), we are removing the address
and replacing it with a website link. We
are correcting the docket number in the
regulations §§ 812.38 and 812.47 with
the docket number specified in the
codified of this rulemaking. For §§ 822.1
and 822.4, we are adding the criterion
from section 522(a)(1)(A)(ii) of the FD&C
Act (21 U.S.C. 360l(a)(1)(A)(ii)) to these
provisions for consistency with the
statutory language. Similarly, we are
amending § 822.24 for consistency with
section 522(b)(1) of the FD&C Act. We
are amending § 822.7(a)(1) by removing
the name of an office that is now
obsolete due to CDRH’s reorganization.
The rule does not impose any new
regulatory requirements on affected
parties. The amendments are editorial in
nature and should not be construed as
modifying any substantive standards or
requirements.
III. Notice and Public Comment
Publication of this document
constitutes final action under the
Administrative Procedure Act (APA) (5
U.S.C. 553). The APA generally exempts
‘‘rules of agency organization,
procedure, or practice’’ from the
requirements of notice and comment
rulemaking (5 U.S.C. 553(b)(A)). Rules
are also generally exempt from such
requirements when an agency ‘‘for good
cause finds (and incorporates the
finding and a brief statement of reasons
therefore in the rules issued) that notice
and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest’’ (5 U.S.C.
553(b)(B)).
FDA has determined that this
rulemaking meets the APA’s notice and
comment exemption requirements. The
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16:41 Mar 20, 2023
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16879
revisions in this rule make technical or
non-substantive changes. Some of these
revisions pertain to the CDRH
reorganization, and constitute ‘‘rules of
agency organization, procedure, or
practice’’ not subject to the
requirements of notice and comment
under 5 U.S.C. 553(b)(A). The balance of
these revisions updates the omitted
language from the statute or the citation
and docket number. Such technical,
non-substantive changes are ‘‘a routine
determination, insignificant in nature
and impact, and inconsequential to the
industry and to the public.’’ Mack
Trucks, Inc. v. EPA, 682 F.3d 87, 94
(D.C. Cir. 2012) (quotation marks and
citation omitted). FDA accordingly for
good cause finds that notice and public
procedure thereon are unnecessary for
these amendments.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). An effective date 30 or
more days from the date of publication
is unnecessary in this case because the
amendments do not impose any new
regulatory requirements on affected
parties, and affected parties do not need
time to ‘‘adjust to the new regulation’’
before the rule takes effect. Am.
Federation of Government Emp., AFL–
CIO v. Block, 655 F.2d 1153, 1156 (D.C.
Cir. 1981). Therefore, FDA finds good
cause for the amendments to become
effective on the date of publication of
this action.
Authority: 5 U.S.C. 551–558, 701–706; 15
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–
397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
List of Subjects
■
21 CFR Part 803
Imports, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 10,
803, 812, and 822 are amended as
follows:
PART 10—ADMINISTRATIVE
PRACTICES AND PROCEDURES
1. The authority citations for part 10
continues to read as follows:
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§ 10.80 Dissemination of draft Federal
Register notices and regulations.
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(h) In accordance with section 534 of
the Federal Food, Drug, and Cosmetic
Act, the Commissioner shall consult
with interested persons and with the
Technical Electronic Product Radiation
Safety Standards Committee (TEPRSSC)
before prescribing any performance
standard for an electronic product.
Accordingly, the Commissioner shall
publish in the Federal Register an
announcement when a proposed or final
performance standard, including any
amendment, is being considered for an
electronic product, and any draft of any
proposed or final standard will be
furnished to an interested person upon
request and may be discussed in detail.
*
*
*
*
*
PART 803—MEDICAL DEVICE
REPORTING
3. The authority citation for part 803
continues to read as follows:
■
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
4. In § 803.19, revise paragraph (b) to
read as follows:
21 CFR Part 10
Administrative practice and
procedure, News media.
■
2. In § 10.80:
a. Remove the headings from
paragraphs (b) and (d); and
■ b. Revise paragraph (h).
The revision reads as follows:
■
■
§ 803.19 Are there exemptions, variances,
or alternative forms of adverse event
reporting requirements?
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(b) If you are a manufacturer,
importer, or user facility, you may
request an exemption or variance from
any or all of the reporting requirements
in this part, including the requirements
of § 803.12. You must submit the
request to the Center for Devices and
Radiological Health (CDRH) in writing
at MDRPolicy@fda.hhs.gov. Your
request must include information
necessary to identify you and the
device; a complete statement of the
request for exemption, variance, or
alternative reporting; and an
explanation why your request is
justified. If you are requesting an
exemption from the requirement to
submit reports to FDA in electronic
format under § 803.12(a), your request
should indicate for how long you will
require this exemption.
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Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Rules and Regulations
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
5. The authority citation for part 812
continues to read as follows:
■
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c–360f, 360h–360j, 360bbb–8b,
371, 372, 374, 379e, 379k–1, 381, 382, 383;
42 U.S.C. 216, 241, 262, 263b–263n.
6. In § 812.38, revise paragraph (b)(4)
to read as follows:
■
§ 812.38 Confidentiality of data and
information.
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*
(b) * * *
(4) Notwithstanding paragraph (b)(2)
of this section, FDA will make available
to the public, upon request, the
information in the IDE that was required
to be filed in Docket Number FDA–
1995–S–0036 in the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
for investigations involving an
exception from informed consent under
§ 50.24 of this chapter. Persons wishing
to request this information shall submit
a request under the Freedom of
Information Act.
*
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*
■ 7. In § 812.47, revise paragraph (a) to
read as follows:
§ 812.47 Emergency research under
§ 50.24 of this chapter.
(a) The sponsor shall monitor the
progress of all investigations involving
an exception from informed consent
under § 50.24 of this chapter. When the
sponsor receives from the IRB
information concerning the public
disclosures under § 50.24(a)(7)(ii) and
(iii) of this chapter, the sponsor shall
promptly submit to the IDE file and to
Docket Number FDA–1995–S–0036 in
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, copies of the information
that was disclosed, identified by the IDE
number.
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*
PART 822—POSTMARKET
SURVEILLANCE
8. The authority citation for part 822
continues to read as follows:
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■
Authority: 21 U.S.C. 331, 352, 360i, 360l,
371, 374.
9. In § 822.1, revise the introductory
text and paragraphs (b) and (c) and add
paragraph (d) to read as follows:
■
§ 822.1
What does this part cover?
This part implements section 522 of
the Federal Food, Drug, and Cosmetic
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16:41 Mar 20, 2023
Jkt 259001
Act by providing procedures and
requirements for postmarket
surveillance of class II and class III
devices that meet any of the following
criteria:
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*
(b) The device is intended to be
implanted in the human body for more
than 1 year;
(c) The device is intended to be used
outside a user facility to support or
sustain life. If you fail to comply with
requirements that we order under
section 522 of the Federal Food, Drug,
and Cosmetic Act and this part, your
device is considered misbranded under
section 502(t)(3) of the Federal Food,
Drug, and Cosmetic Act and you are in
violation of section 301(q)(1)(C) of the
Federal Food, Drug, and Cosmetic Act;
or
(d) The device is expected to have
significant use in pediatric populations.
■ 10. In § 822.4, revise the introductory
text and paragraphs (b) and (c) and add
paragraph (d) to read as follows:
§ 822.4
Does this part apply to me?
If we have ordered you to conduct
postmarket surveillance of a medical
device under section 522 of the Federal
Food, Drug, and Cosmetic Act, this part
applies to you. We have the authority to
order postmarket surveillance of any
class II or class III medical device,
including a device reviewed under the
licensing provisions of section 351 of
the Public Health Service Act, that
meets any of the following criteria:
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*
*
(b) The device is intended to be
implanted in the human body for more
than 1 year;
(c) The device is intended to be used
to support or sustain life and to be used
outside a user facility; or
(d) The device is expected to have
significant use in pediatric populations.
■ 11. In § 822.7, revise paragraph (a)(1)
to read as follows:
§ 822.7 What should I do if I do not agree
that postmarket surveillance is
appropriate?
(a) * * *
(1) Requesting a meeting with the
Director of the Office that issued the
order for postmarket surveillance;
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■ 12. Revise § 822.24 to read as follows:
§ 822.24 What are my responsibilities once
I am notified that I am required to conduct
postmarket surveillance?
You must submit your plan to
conduct postmarket surveillance to us
within 30 days from receipt of the order
(letter) notifying you that you are
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required to conduct postmarket
surveillance of a device. The
manufacturer shall commence
surveillance not later than 15 months
after the day the order was issued.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05657 Filed 3–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1952
Maine State Plan for State and Local
Government Employees; Approval of
Plan Supplements and Certification of
Completion of Developmental Steps
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notification of certification of
the State Plan.
AGENCY:
The Maine Department of
Labor, Bureau of Labor Standards
submitted documentation attesting to
the completion of all structural and
developmental aspects of its State Plan
for State and Local Government
Employees as approved by OSHA. After
extensive review of the submissions and
opportunity for correction, the Maine
State Plan (MEOSH) submitted updated
and revised documents. OSHA is
approving the revised State Plan, which
documents the satisfactory completion
of all structural and developmental
aspects of Maine’s approved State Plan,
and is certifying this completion. This
certification attests to the fact that the
Maine State Plan now has in place those
structural components necessary for an
effective State Plan for State and Local
Government Employees. (Enforcement
of occupational safety and health
standards with regard to private sector
employers and employees in the State of
Maine remains the responsibility of the
U.S. Department of Labor, OSHA.)
DATES: Effective March 21, 2023.
FOR FURTHER INFORMATION CONTACT:
For press inquiries: Contact Frank
Meilinger, OSHA Office of
Communications, U.S. Department of
Labor; telephone (202) 693–1999; email
meilinger.francis2@dol.gov.
For general and technical
information: Contact Douglas J.
Kalinowski, Director, OSHA Directorate
of Cooperative and State Programs, U.S.
Department of Labor; telephone (202)
693–2200; email: kalinowski.doug@
dol.gov.
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Rules and Regulations]
[Pages 16878-16880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05657]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 10, 803, 812, and 822
[Docket No. FDA-2021-N-0246]
Medical Devices; Technical Amendments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending certain medical device regulations to update mailing address
and docket number and conform the regulatory provisions to the Federal
Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any
new regulatory requirements on affected parties. This action is
editorial in nature to correct errors and to ensure accuracy and
clarity in the Agency's regulations.
DATES: This rule is effective March 21, 2023.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of
Policy, Center for Devices and
[[Page 16879]]
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION:
I. Background
As a part of this technical amendment, the FDA Center for Devices
and Radiological Health (CDRH) is making changes to 21 CFR parts 10,
803, 812, and 822 to revise contact addresses, correct docket numbers,
and conform the regulatory provisions to the FD&C Act to ensure
accuracy and clarity in the Agency's medical device regulations. The
changes published in this notice are non-substantive and editorial in
nature.
II. Description of the Technical Amendments
The regulation, 21 CFR 10.80(h), is being revised to make a non-
substantive editorial change to update a citation that was moved from
title 42 to title 21. In Sec. 803.19(b), we are removing the address
and replacing it with a website link. We are correcting the docket
number in the regulations Sec. Sec. 812.38 and 812.47 with the docket
number specified in the codified of this rulemaking. For Sec. Sec.
822.1 and 822.4, we are adding the criterion from section
522(a)(1)(A)(ii) of the FD&C Act (21 U.S.C. 360l(a)(1)(A)(ii)) to these
provisions for consistency with the statutory language. Similarly, we
are amending Sec. 822.24 for consistency with section 522(b)(1) of the
FD&C Act. We are amending Sec. 822.7(a)(1) by removing the name of an
office that is now obsolete due to CDRH's reorganization. The rule does
not impose any new regulatory requirements on affected parties. The
amendments are editorial in nature and should not be construed as
modifying any substantive standards or requirements.
III. Notice and Public Comment
Publication of this document constitutes final action under the
Administrative Procedure Act (APA) (5 U.S.C. 553). The APA generally
exempts ``rules of agency organization, procedure, or practice'' from
the requirements of notice and comment rulemaking (5 U.S.C. 553(b)(A)).
Rules are also generally exempt from such requirements when an agency
``for good cause finds (and incorporates the finding and a brief
statement of reasons therefore in the rules issued) that notice and
public procedure thereon are impracticable, unnecessary, or contrary to
the public interest'' (5 U.S.C. 553(b)(B)).
FDA has determined that this rulemaking meets the APA's notice and
comment exemption requirements. The revisions in this rule make
technical or non-substantive changes. Some of these revisions pertain
to the CDRH reorganization, and constitute ``rules of agency
organization, procedure, or practice'' not subject to the requirements
of notice and comment under 5 U.S.C. 553(b)(A). The balance of these
revisions updates the omitted language from the statute or the citation
and docket number. Such technical, non-substantive changes are ``a
routine determination, insignificant in nature and impact, and
inconsequential to the industry and to the public.'' Mack Trucks, Inc.
v. EPA, 682 F.3d 87, 94 (D.C. Cir. 2012) (quotation marks and citation
omitted). FDA accordingly for good cause finds that notice and public
procedure thereon are unnecessary for these amendments.
The APA allows an effective date less than 30 days after
publication as ``provided by the agency for good cause found and
published with the rule'' (5 U.S.C. 553(d)(3)). An effective date 30 or
more days from the date of publication is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties, and affected parties do not need time to ``adjust to
the new regulation'' before the rule takes effect. Am. Federation of
Government Emp., AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir.
1981). Therefore, FDA finds good cause for the amendments to become
effective on the date of publication of this action.
List of Subjects
21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under the authority delegated to the Commissioner of Food and Drugs, 21
CFR parts 10, 803, 812, and 822 are amended as follows:
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
0
1. The authority citations for part 10 continues to read as follows:
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
0
2. In Sec. 10.80:
0
a. Remove the headings from paragraphs (b) and (d); and
0
b. Revise paragraph (h).
The revision reads as follows:
Sec. 10.80 Dissemination of draft Federal Register notices and
regulations.
* * * * *
(h) In accordance with section 534 of the Federal Food, Drug, and
Cosmetic Act, the Commissioner shall consult with interested persons
and with the Technical Electronic Product Radiation Safety Standards
Committee (TEPRSSC) before prescribing any performance standard for an
electronic product. Accordingly, the Commissioner shall publish in the
Federal Register an announcement when a proposed or final performance
standard, including any amendment, is being considered for an
electronic product, and any draft of any proposed or final standard
will be furnished to an interested person upon request and may be
discussed in detail.
* * * * *
PART 803--MEDICAL DEVICE REPORTING
0
3. The authority citation for part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
4. In Sec. 803.19, revise paragraph (b) to read as follows:
Sec. 803.19 Are there exemptions, variances, or alternative forms of
adverse event reporting requirements?
* * * * *
(b) If you are a manufacturer, importer, or user facility, you may
request an exemption or variance from any or all of the reporting
requirements in this part, including the requirements of Sec. 803.12.
You must submit the request to the Center for Devices and Radiological
Health (CDRH) in writing at [email protected]. Your request must
include information necessary to identify you and the device; a
complete statement of the request for exemption, variance, or
alternative reporting; and an explanation why your request is
justified. If you are requesting an exemption from the requirement to
submit reports to FDA in electronic format under Sec. 803.12(a), your
request should indicate for how long you will require this exemption.
* * * * *
[[Page 16880]]
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
5. The authority citation for part 812 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42
U.S.C. 216, 241, 262, 263b-263n.
0
6. In Sec. 812.38, revise paragraph (b)(4) to read as follows:
Sec. 812.38 Confidentiality of data and information.
* * * * *
(b) * * *
(4) Notwithstanding paragraph (b)(2) of this section, FDA will make
available to the public, upon request, the information in the IDE that
was required to be filed in Docket Number FDA-1995-S-0036 in the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, for investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. Persons wishing to request this information shall submit a
request under the Freedom of Information Act.
* * * * *
0
7. In Sec. 812.47, revise paragraph (a) to read as follows:
Sec. 812.47 Emergency research under Sec. 50.24 of this chapter.
(a) The sponsor shall monitor the progress of all investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. When the sponsor receives from the IRB information concerning
the public disclosures under Sec. 50.24(a)(7)(ii) and (iii) of this
chapter, the sponsor shall promptly submit to the IDE file and to
Docket Number FDA-1995-S-0036 in the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, copies of the information that was disclosed,
identified by the IDE number.
* * * * *
PART 822--POSTMARKET SURVEILLANCE
0
8. The authority citation for part 822 continues to read as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
9. In Sec. 822.1, revise the introductory text and paragraphs (b) and
(c) and add paragraph (d) to read as follows:
Sec. 822.1 What does this part cover?
This part implements section 522 of the Federal Food, Drug, and
Cosmetic Act by providing procedures and requirements for postmarket
surveillance of class II and class III devices that meet any of the
following criteria:
* * * * *
(b) The device is intended to be implanted in the human body for
more than 1 year;
(c) The device is intended to be used outside a user facility to
support or sustain life. If you fail to comply with requirements that
we order under section 522 of the Federal Food, Drug, and Cosmetic Act
and this part, your device is considered misbranded under section
502(t)(3) of the Federal Food, Drug, and Cosmetic Act and you are in
violation of section 301(q)(1)(C) of the Federal Food, Drug, and
Cosmetic Act; or
(d) The device is expected to have significant use in pediatric
populations.
0
10. In Sec. 822.4, revise the introductory text and paragraphs (b) and
(c) and add paragraph (d) to read as follows:
Sec. 822.4 Does this part apply to me?
If we have ordered you to conduct postmarket surveillance of a
medical device under section 522 of the Federal Food, Drug, and
Cosmetic Act, this part applies to you. We have the authority to order
postmarket surveillance of any class II or class III medical device,
including a device reviewed under the licensing provisions of section
351 of the Public Health Service Act, that meets any of the following
criteria:
* * * * *
(b) The device is intended to be implanted in the human body for
more than 1 year;
(c) The device is intended to be used to support or sustain life
and to be used outside a user facility; or
(d) The device is expected to have significant use in pediatric
populations.
0
11. In Sec. 822.7, revise paragraph (a)(1) to read as follows:
Sec. 822.7 What should I do if I do not agree that postmarket
surveillance is appropriate?
(a) * * *
(1) Requesting a meeting with the Director of the Office that
issued the order for postmarket surveillance;
* * * * *
0
12. Revise Sec. 822.24 to read as follows:
Sec. 822.24 What are my responsibilities once I am notified that I am
required to conduct postmarket surveillance?
You must submit your plan to conduct postmarket surveillance to us
within 30 days from receipt of the order (letter) notifying you that
you are required to conduct postmarket surveillance of a device. The
manufacturer shall commence surveillance not later than 15 months after
the day the order was issued.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05657 Filed 3-20-23; 8:45 am]
BILLING CODE 4164-01-P
