Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments, 27463-27467 [2012-11262]
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Federal Register / Vol. 77, No. 91 / Thursday, May 10, 2012 / Notices
other FDA documents regarding the
general content and format requirements
of a 510(k) submission.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on information necessary to establish
substantial equivalence to a predicate
device and thus provide reasonable
assurance of the safety and effectiveness
for x-ray imaging devices that may be
used on pediatric populations. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
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III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. The FDA draft guidance
entitled ‘‘Pediatric Information for X-ray
Imaging Device Premarket
Notifications’’ is available at https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Guidance
Documents/ucm300850.htm. Guidance
documents are also available at https://
www.regulations.gov. To receive
‘‘Pediatric Information for X-ray Imaging
Device Premarket Notifications,’’ you
may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1771 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; and the collections
of information in 21 CFR parts 1002,
1010, 1020, 1030, 1040, and 1050 have
been approved under OMB control
number 0910–0025. In addition, FDA
concludes that the Indications for Use
warning label does not constitute a
‘‘collection of information’’ under the
PRA. Rather, the labeling statements are
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‘‘public disclosure[s] of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public.’’
(5 CFR 1320.3(c)(2)).
V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. NAS National Research Council
Committee to Assess Health Risks from
Exposure to Low Levels of Ionizing
Radiation, ‘‘Health risks from exposure
to low levels of ionizing radiation: BEIR
VII phase 2.’’ Washington, DC: National
Academy of Sciences, National
Academies Press, 2006.
2. Larson, D.B. et al., ‘‘Rising Use of CT in
Child Visits to the Emergency
Department in the United States, 1995–
2008,’’ Radiology, vol. 259(3), pp. 793–
801, 2011.
3. The FDA pediatric guidance entitled
‘‘Premarket Assessment of Pediatric
Medical Devices,’’ available at https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Guidance
Documents/ucm089740.htm, 2004.
4. The FDA initiative entitled ‘‘Initiative to
Reduce Unnecessary Radiation Exposure
from Medical Imaging,’’ available at
https://www.fda.gov/Radiation-Emitting
Products/RadiationSafety/RadiationDose
Reduction/default.htm.
5. The recommendations from pediatric
experts at FDA’s Public Meeting: Device
Improvements to Reduce Unnecessary
Radiation Exposure from Medical
Imaging, available at https://www.fda.gov/
MedicalDevices/NewsEvents/Workshops
Conferences/ucm201448.htm, March 30–
31, 2010.
VI. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–11260 Filed 5–9–12; 8:45 am]
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27463
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0385]
Device Improvements for Pediatric XRay Imaging; Public Meeting; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting; request for
comments.
ACTION:
FDA is announcing the
following public meeting on the draft
guidance ‘‘Pediatric Information for Xray Imaging Device Premarket
Notifications.’’ This guidance will apply
to x-ray computed tomography, general
and dental radiography, and diagnostic
and interventional fluoroscopy devices.
FDA has organized this meeting to
solicit public feedback on the draft
guidance and to help identify issues
relevant to radiation safety in pediatric
x-ray imaging that may benefit from
standards development or further
research.
SUMMARY:
Date and Time: The meeting will
be held on July 16, 2012, from 8 a.m. to
5 p.m.
Location: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
Contact: Thalia Mills, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4527,
Silver Spring, MD 20993, 301–796–
6641, FAX: 301–847–8502, email:
Thalia.Mills@fda.hhs.gov.
Registration: Registration is free and
on a first-come, first-served basis.
Persons interested in attending this
meeting, but not requesting to speak or
participate in the roundtable, must
register online by 5 p.m. on July 9, 2012.
Note that all meeting participants will
be able to listen to all the presentations
and roundtable discussion, as well as
submit questions for the roundtable
during the meeting. Early registration is
recommended because facilities are
limited, and therefore, FDA may also
limit the number of participants from
DATES:
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each organization. If time and space
permit, onsite registration on the day of
the public workshop will be provided
beginning at 7:30 a.m. If you need
special accommodations due to a
disability, please contact Cindy Garris
(email: Cynthia.Garris@fda.hhs.gov or
phone: 301–796–5861) no later than July
9, 2012.
To register for the meeting, please
visit the following Web site: https://
www.fda.gov/MedicalDevices/News
Events/WorkshopsConferences (select
this public workshop from the posted
events list). Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone number.
Those without Internet access should
contact Cindy Garris (email:
Cynthia.Garris@fda.hhs.gov or phone:
301–796–5861) for registration.
Registrants will receive confirmation
once they have been accepted. You will
be notified if you are on a waiting list.
Streaming Webcast of Pediatric X-ray
Imaging Meeting: This meeting will also
be webcast. Persons interested in
viewing the webcast must register
online by 5 p.m. on July 9, 2012. Early
registration is recommended because
webcast connections are limited.
Organizations are requested to register
all participants, but to view using one
connection per location. Webcast
participants will be sent technical
system requirements after registration,
and will be sent connection access
information after July 12, 2012. If you
have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview.
Requests for Oral Presentations: This
meeting includes a public comment
session. During online registration you
may indicate if you wish to make an
oral presentation during the public
comment session, and the topic you
wish to address in your presentation. If
you wish to make a presentation during
the public comment session, you must
register online by 5 p.m. on June 25,
2012. FDA has included topics and
questions for comment in this
document. FDA will do its best to
accommodate requests to make public
comment. Individuals and organizations
with common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the public comment session.
Following the close of registration, FDA
will determine the amount of time
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allotted to each presenter and the
approximate time each oral presentation
is to begin, and will select and notify
participants. All requests to make oral
presentations must be made at the time
of registration. Presentation materials
for selected oral presentations must be
emailed to Thalia Mills no later than
July 9, 2012. No commercial or
promotional material will be permitted
to be presented or distributed at the
meeting.
Requests to Participate in Roundtable
Discussion: This workshop also
includes a roundtable discussion.
During online registration you may
indicate if you wish to participate in the
roundtable discussion. If you wish to
request to participate, you must register
online by 5 p.m. on June 25, 2012. The
number of roundtable participants will
be limited, but all meeting participants
will have the opportunity to view and
submit questions to the roundtable. A
request to be a participant does not
guarantee a place in the roundtable
discussion; participants will be chosen
to represent a broad variety of
specialties.
Comments: FDA is holding this public
meeting to obtain public comment on
the draft guidance ‘‘Pediatric
Information for X-ray Imaging Device
Premarket Notifications.’’ Relevant
issues include device design features,
labeling information, and testing
specific to pediatric use. The deadline
for submitting comments related to this
public meeting is September 7, 2012.
Regardless of attendance at the public
meeting, interested persons may submit
written or electronic comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. It is only
necessary to submit one set of
comments. Please identify comments
with the docket number found in the
brackets in the heading of this notice. In
addition, when responding to specific
questions as outlined in section IV of
this document, please identify the
question that you are addressing.
Received written comments may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday. Electronic comments
can be viewed in the public docket for
this meeting at https://
www.regulations.gov.
Transcripts: As soon as a transcript is
available, it will be accessible at
https://www.regulations.gov. It may also
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
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also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
The development of this draft
guidance is part of FDA’s larger
Initiative to Reduce Unnecessary
Radiation Exposure from Medical
Imaging (Ref. 1). While the benefit of a
clinically appropriate x-ray imaging
exam far outweighs the risk, efforts
should be made to minimize this risk by
reducing unnecessary exposure to
ionizing radiation. Ionizing radiation
exposure to pediatric patients from
medical imaging procedures is of
particular concern to the Agency for
three reasons: (1) Younger patients are
more radiosensitive than adults (i.e., the
cancer risk per unit dose of ionizing
radiation is higher) (Ref. 2); (2) younger
patients have a longer expected lifetime
for the effects of radiation exposure to
manifest as cancer; and (3) use of
equipment and exposure settings
designed for adults can result in
excessive radiation exposure for the
smaller patient. The third point is of
special concern because many pediatric
imaging exams are performed in
facilities lacking specialized expertise in
pediatric imaging (Ref. 3).
On March 30 and 31, 2010, the
Agency held a public meeting entitled
‘‘Device Improvements to Reduce
Unnecessary Radiation Exposure from
Medical Imaging’’ (Ref. 4). The Agency
asked whether manufacturers should
incorporate special provisions for
pediatric patients, particularly with
regard to hardware and software
features (Ref. 5). Recommendations
received by FDA, which apply to all
general-use x-ray imaging modalities,
included making available pediatric
protocols and control settings, targeted
instructions and educational materials
emphasizing pediatric dose reduction,
quality assurance tools for facilities
emphasizing radiation dose
management, and dose information
applicable to pediatric patients. Many of
the recommendations from pediatric
experts focused on expanding the
flexibility or range of features already
available on x-ray imaging devices,
which may also improve adult imaging
for non-standard applications.
At the March 2010 meeting, experts
commented that many radiological
devices are sold without the design
features or labeling information that
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would help users optimize benefit
(clinically-usable images) in comparison
to risk (radiation exposure) for pediatric
imaging (Ref. 6). Imaging professionals
can safely use existing equipment that
may not have specific features or
instructions for pediatric use by
consulting recommendations provided
by the Alliance for Radiation Safety in
Pediatric Imaging (ARSPI) and other
organizations. FDA has reviewed the
recommendations from ARSPI and
believes they are appropriate. Because
of the special concerns about excessive
exposure to radiation in children, FDA
believes that new x-ray imaging devices
should be demonstrated to be
appropriate for pediatric use or use in
pediatric populations should be
cautioned against. The end user can
then make more informed decisions
about use of the device on pediatric
patients. FDA has therefore published a
draft guidance entitled ‘‘Pediatric
Information for X-ray Imaging Device
Premarket Notifications’’ and is holding
this public meeting to solicit public
comment on the draft guidance and
broader radiation safety issues for use of
x-ray imaging devices on pediatric
populations (Ref. 7).
In addition to drafting guidance, FDA
is also engaged in complementary
outreach efforts aimed at providing
imaging practitioners with tools to
reduce dose to pediatric patients. The
Center for Devices and Radiological
Health and FDA’s Critical Path Program
funded two contracts awarded in 2010
and 2011 to the Alliance for Radiation
Safety in Pediatric Imaging. The goal of
the work is to develop improved
training material and instructions for
pediatric digital radiography (Ref. 8)
and fluoroscopy (ongoing project).
These materials will be publicly
available as a resource to both imaging
facilities and device manufacturers.
FDA believes that engaging in such
partnerships with professional
organizations helps ensure that the end
user perspective is incorporated into
improved device features, instructions,
and training.
In order to inform health care
professionals and the public, FDA has
also posted a new Web page on
Pediatric X-ray Imaging (Ref. 9). More
information on the benefits and risks of
x-ray imaging, as well as radiation safety
recommendations and resources specific
to pediatric patients, can be found on
this Web page.
II. Draft Guidance: Pediatric
Information for X-Ray Imaging Device
Premarket Notifications
Elsewhere in this issue of the Federal
Register, FDA is announcing the
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availability of the draft guidance
entitled ‘‘Pediatric Information for X-ray
Imaging Device Premarket
Notifications.’’ This draft guidance
document provides industry and
Agency staff with FDA’s current
thinking on information that should be
provided in premarket notifications for
x-ray imaging devices with indications
for use in pediatric populations. The
Agency intends for this guidance to
minimize uncertainty during the
premarket review process of 510(k)s for
x-ray imaging devices for pediatric use,
to encourage the inclusion of pediatric
indications for use for x-ray imaging
device premarket notifications, and to
provide recommendations on
information to support such indications.
This draft guidance is not final nor is it
in effect at this time.
The draft guidance provides as
follows: ‘‘Manufacturers seeking
marketing clearance for a new x-ray
imaging device with a pediatric
indication should provide data
supporting the safety and effectiveness
of the device in pediatric populations.
Manufacturers who seek marketing
clearance only for general indications or
do not submit adequate data to the FDA
to support a pediatric indication for use
for x-ray imaging devices where
pediatric use is likely should label their
x-ray imaging device with the statement
‘CAUTION: Not for use on patients less
than approximately [insert patient size
(e.g., body part thickness or height and
weight appropriate to your device)].’ as
part of the IFU statement. This
statement should also be prominently
displayed on the device itself (e.g.,
control panel). The statement should be
revised depending on the size
subgroups (see section 4 of the draft
guidance) for which manufacturers
submit data.’’ (Ref. 10).
This draft guidance applies only to
complete x-ray imaging devices that
could be used on pediatric patients (e.g.,
x-ray computed tomography, general
and dental radiography, and diagnostic
and interventional fluoroscopy devices).
The guidance is intended to be used in
conjunction with other guidance
specific to particular x-ray imaging
modalities.
III. Purpose and Scope of the Meeting
Before the draft guidance ‘‘Pediatric
Information for X-ray Imaging Device
Premarket Notifications’’ is finalized,
FDA believes it is crucial to receive
public input from both industry and xray imaging device users, particularly
from those with pediatric expertise, on
the overall effort and on a number of
specific questions (see section IV of this
document). In order to assist the public
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in providing targeted comments, the
FDA will present general background
information on the 510(k) clearance
process, the role of guidance, and the
FDA’s approach to pediatric use of
medical devices.
In addition to discussion of the
guidance itself, another goal of this
meeting is to help identify issues
relevant to radiation safety in pediatric
x-ray imaging that may benefit from
standards development or further
research. FDA recognizes that a one-day
meeting cannot cover all the relevant
issues; we are therefore soliciting ideas
on how device manufacturers,
professional organizations, and FDA can
best follow up on the issues identified
through a coordinated effort.
IV. Specific Questions for Discussion at
the Public Meeting
In your submissions to the public
docket and in oral presentations, please
consider the following questions. FDA
will also consider your comments on
topics related to safe and effective use
of x-ray imaging devices on pediatric
populations that are not covered by the
questions below or the draft guidance:
1. While radiation-induced cancer
risk depends on a number of factors
including the patient’s age, patient size
(not age) is a major factor in
optimization of radiation exposure vs.
image quality. Although CDRH has
defined the ‘‘pediatric population’’ as
including patients from birth to 21 years
(Ref. 11), Section 4—‘‘Pediatric
population’’ of the draft guidance
divides the pediatric population into
subgroups based on patient size rather
than age. The intent of the draft
guidance is to extend the range of
testing and labeling information to small
pediatric patients that may not be
covered in adult size ranges. Please
provide comments on how pediatric
subgroups are covered in the guidance
with respect to labeling information and
testing data. Specifically:
a. In the suggested language for the
example caution statement to appear in
the labeling, FDA assumed that if a
device is designed for a broad range of
adults, it will be capable of imaging
patients over about 50 kg in weight and
150 cm in height. In your experience,
are most general-use x-ray imaging
devices adequately designed for patients
over this size? Is the overall wording of
the suggested example caution
statement appropriate? The example
statement referred to in this question
reads: ‘‘CAUTION: This device is not
intended for use on patients less than
approximately 50 kg (110 lb) in weight
and 150 cm (59 in) in height; these
height and weight measurements
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approximately correspond to that of an
average 12 year old or a 5th percentile
U.S. adult female [Ref. 12]. Use of
equipment and exposure settings
designed for adults of average size can
result in excessive radiation exposure
for a smaller patient. Studies have
shown that pediatric patients may be
more radiosensitive than adults (i.e. the
cancer risk per unit dose of ionizing
radiation is higher), and so unnecessary
radiation exposure is of particular
concern for pediatric patients [Ref. 13].’’
b. The draft guidance states that
patient thickness is a more appropriate
metric than height and weight for
describing populations and gives
references to literature data for
thickness or circumference. Which
metric should be used in defining
subgroups (e.g., anteroposterior and
transverse body diameter or
circumference)? Is it appropriate to
choose one body region (e.g., chest or
abdomen) to generally categorize
population subgroups in terms of
thickness or circumference?
c. For tests that require phantoms,
how many different sized phantoms
should be tested for a sponsor to
demonstrate safe pediatric use? Would a
large adult-sized phantom and a small
pediatric-sized phantom be sufficient to
demonstrate coverage of the entire range
of patient sizes? (Currently the draft
guidance recommends at a minimum a
range of phantoms that represent birth1 month, 1-year old, 5-year old, 12-year
old, and adult sizes.)
d. For tests that do not involve
phantoms, the document states ‘‘that the
range of settings and conditions for
testing include those that would
normally be used during pediatric
imaging’’ (see Section 9 of the draft
guidance). Do you have suggestions on
how this range should be covered? (e.g.,
would it be acceptable to perform tests
with settings matching those used only
on the smallest and largest patients?)
2. In the 510(k) premarket review
process, FDA relies on the concept of
‘‘substantial equivalence’’ to a predicate
device to demonstrate safe and effective
use. The submitter of a 510(k) must
provide a statement of the intended use
of the device. If the device has specific
indications for use that are different
from those of the predicate device, the
510(k) summary must contain an
explanation as to why the differences do
not affect the safety and effectiveness of
the device when used as labeled (Ref.
14). Because many predicate x-ray
imaging devices that are on the market
do not have a specific indication for
pediatric use, new x-ray imaging
devices with a specific indication for
pediatric use will have to demonstrate
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that they are as safe and effective as the
predicate devices that are not indicated
for pediatric use. Especially with regard
to sections 9 (Laboratory Image Quality
and Dose Assessment) and 10 (Clinical
Image Quality Assessment) in the draft
guidance, FDA has outstanding
questions regarding how to demonstrate
that an x-ray imaging device that has a
specific indication for pediatric use is as
safe and effective as an x-ray imaging
device with only a general indication for
use:
a. Can you think of a situation where
phantom testing (objective image quality
and dose assessment) alone would be
insufficient to demonstrate safe and
effective pediatric use and clinical data
would be necessary?
b. In those cases, would it be
acceptable to provide images of
anthropomorphic phantoms instead of
pediatric patients?
3. As currently written, the draft
guidance document recommends that
any performance characteristics
expected to change based on the size of
the object being imaged should be tested
specifically for pediatric use. FDA
requests help identifying what these
tests are, i.e., which device features are
size-dependent? (Tube current
modulation and/or automatic exposure
control and data collection speed are
examples.) Because this guidance
document is intended to cover all x-ray
imaging devices that could be used on
pediatric patients, this question relates
specifically to x-ray computed
tomography, fluoroscopy, and general
and dental radiography devices.
4. Table 3 in the Appendix of the draft
guidance lists specific pediatric issues
currently addressed by applicable
standards. Establishing safe and
effective use of x-ray imaging devices on
pediatric populations may involve
special design features, labeling (e.g.
instructions for use) and training
information, and performance tests. The
guidance covers these topics generally,
but each modality will have different
issues. A variety of approaches for these
topics exist in the literature, but in
many cases it may be beneficial if the
x-ray imaging community further
developed prioritized, consensus
recommendations. FDA participates in
development of national and
international standards. While FDA
does not control the content of these
standards, standards liaisons can make
recommendations. Do you have specific
recommendations for pediatric use
issues that should be covered by
standards for performance features,
testing, or labeling?
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V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. FDA White Paper, ‘‘Initiative to Reduce
Unnecessary Radiation Exposure from
Medical Imaging,’’ available at https://
www.fda.gov/RadiationEmitting
Products/RadiationSafety/RadiationDose
Reduction/default.htm, February 2010.
2. National Research Council of the National
Academies, Committee to Assess Health
Risks from Exposure to Low Levels of
Ionizing Radiation, ‘‘Health Risks from
Exposure to Low Levels of Ionizing
Radiation: BEIR VII Phase,’’ National
Academy of Sciences (National
Academies Press, 2006).
3. For example, the following study found
that non-pediatric focused emergency
departments made up 89.4 percent of
emergency department visits associated
with CT (computed tomography) in
children: Larson, D.B., et al., ‘‘Rising Use
of CT in Child Visits to the Emergency
Department in the United States, 1995–
2008,’’ Radiology, 259(3), 793–801, 2011.
4. FDA Public Meeting: Device Improvements
to Reduce Unnecessary Radiation
Exposure from Medical Imaging, March
30–31, 2010, agenda and transcripts,
available at https://www.fda.gov/Medical
Devices/NewsEvents/Workshops
Conferences/ucm201448.htm, public
docket submissions, available at
https://www.regulations.gov/#!docket
Detail;rpp=10;po=0;D=FDA-2010-N0080.
5. The Federal Register notice (75 FR 8375–
8377) lists all the questions asked at the
meeting, February 24, 2010, available at
https://edocket.access.gpo.gov/2010/2010
-3674.htm.
6. The principles of radiation protection in
medicine, including ‘‘optimization’’ are
described in ‘‘Radiological Protection in
Medicine, International Commission on
Radiological Protection,’’ Annals of the
ICRP, 37(6), 2007. Optimization of
radiation exposure for x-ray imaging
means the following: Examinations
should use techniques that are adjusted
to administer the lowest radiation dose
that yields an image quality adequate for
diagnosis or intervention (i.e., radiation
doses should be ‘‘As Low as Reasonably
Achievable’’ (ALARA)).
7. The FDA draft guidance entitled ‘‘Pediatric
Information for X-ray Imaging Device
Premarket Notifications,’’ is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm300850.htm.
8. The Image Gently/FDA Digital
Radiography Safety Checklist and
accompanying documents are available
at https://www.pedrad.org/associations/
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Federal Register / Vol. 77, No. 91 / Thursday, May 10, 2012 / Notices
5364/ig/index.cfm?page=775.
9. The FDA Web page for information on
Pediatric X-ray Imaging, is available at
https://www.fda.gov/RadiationEmitting
Products/RadiationEmittingProductsand
Procedures/MedicalImaging/
ucm298899.htm.
10. Under section 513(i)(1)(E)(i) of the
Federal Food, Drug, and Cosmetic Act,
when determining that a device is
substantially equivalent to a predicate
device, FDA may require limitations in
device labeling about off-label use of the
device when ‘‘there is a reasonable
likelihood’’ of such use, and if ‘‘such use
could cause harm.’’ Such determinations
are made on a case by case basis and
other requirements must be met,
including a consultation between FDA
and the 510(k) submitter, before such
limitations can be required. FDA’s policy
on when a device may be found
‘‘substantially equivalent with
limitations’’ is discussed further in the
guidance entitled ‘‘Determination of
Intended Use for 510(k) Devices;
Guidance for CDRH Staff (Update to
K98–1),’’ available at https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Guidance
Documents/ucm082162.htm, December
3, 2003.
11. The FDA guidance entitled ‘‘Premarket
Assessment of Pediatric Medical
Devices,’’ is available at https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm089742.pdf,
May 14, 2004.
12. McDowell, M.A., C.D. Fryar, C.L. Ogden,
and K. M. Flegal, ‘‘Anthropomorphic
Reference Data for Children and Adults:
United States, 2003–2006,’’ National
Health Statistics Reports, vol. 10, 1–48,
available at https://www.cdc.gov/nchs/
data/nhsr/nhsr010.pdf, October 22,
2008.
13. National Research Council of the National
Academies, Committee to Assess Health
Risks from Exposure to Low Levels of
Ionizing Radiation, ‘‘Health Risks from
Exposure to Low Levels of Ionizing
Radiation: BEIR VII Phase,’’ National
Academy of Sciences (National
Academies Press), is available at https://
www.nap.edu/openbook.php?isbn=
030909156X, 2006.
14. See 21 CFR 807.92.
Dated: May 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–11262 Filed 5–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Proposed Information Collection;
Request for Public Comment: Indian
Health Service Loan Repayment
Program (LRP)
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, which requires
30 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
project was previously published in the
Federal Register (77 FR 11558) on
February 27, 2012 and allowed 60 days
for public comment. No public
comment was received in response to
the notice. The purpose of this notice is
to allow 30 days for public comment to
be submitted directly to OMB.
Proposed Collection: Title: 0917–
0014, ‘‘Indian Health Service Loan
Repayment Program.’’ Type of
Information Collection Request:
Revision of currently approved
information collection, 0917–0014,
‘‘Indian Health Service Loan Repayment
Program.’’ The LRP application has been
revised so that it is now available in an
electronically fillable and fileable
SUMMARY:
format. Form(s): The IHS LRP
Information Booklet contains the
instructions and the application
formats. Need and Use of Information
Collection: The IHS LRP identifies
health professionals with pre-existing
financial obligations for education
expenses that meet program criteria and
who are qualified and willing to serve
at, often remote, IHS health care
facilities. Under the program, eligible
health professionals sign a contract
through which the IHS agrees to repay
part or all of their indebtedness for
professional training time in IHS health
care facilities. This program is necessary
to augment the critically low health
professional staff at IHS health care
facilities.
Any health professional wishing to
have their health education loans repaid
may apply to the IHS LRP. A two-year
contract obligation is signed by both
parties, and the individual agrees to
work at an IHS location and provide
health services to American Indian and
Alaska Native individuals.
The information collected via the online application from individuals is
analyzed and a score is given to each
applicant. This score will determine
which applicants will be awarded each
fiscal year. The administrative scoring
system assigns a score to the geographic
location according to vacancy rates for
that fiscal year and also considers
whether the location is in an isolated
area. When an applicant accepts
employment at a location, they in turn
‘‘pick-up’’ the score of that location.
Affected Public: Individuals and
households. Type of Respondents:
Individuals.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Annual
number of responses, Average burden
hour per response, and Total annual
burden hour(s).
ESTIMATED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
(in hours)
LRP Application ...............................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Data collection instrument(s)
510
1
1.5
765
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Requests for Comments: Your
comments and/or suggestions are
invited on one or more of the following
points:
VerDate Mar<15>2010
17:18 May 09, 2012
Jkt 226001
(a) Whether the information collection
activity is necessary to carry out an
agency function;
(b) Whether the agency processes the
information collected in a useful and
timely fashion;
(c) The accuracy of public burden
estimate (the estimated amount of time
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
needed for individual respondents to
provide the requested information);
(d) Whether the methodology and
assumptions used to determine the
estimates are logical;
(e) Ways to enhance the quality,
utility, and clarity of the information
being collected; and
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 77, Number 91 (Thursday, May 10, 2012)]
[Notices]
[Pages 27463-27467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0385]
Device Improvements for Pediatric X-Ray Imaging; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: FDA is announcing the following public meeting on the draft
guidance ``Pediatric Information for X-ray Imaging Device Premarket
Notifications.'' This guidance will apply to x-ray computed tomography,
general and dental radiography, and diagnostic and interventional
fluoroscopy devices. FDA has organized this meeting to solicit public
feedback on the draft guidance and to help identify issues relevant to
radiation safety in pediatric x-ray imaging that may benefit from
standards development or further research.
DATES: Date and Time: The meeting will be held on July 16, 2012, from 8
a.m. to 5 p.m.
Location: The meeting will be held at FDA White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993-0002. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact: Thalia Mills, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
4527, Silver Spring, MD 20993, 301-796-6641, FAX: 301-847-8502, email:
Thalia.Mills@fda.hhs.gov.
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this meeting, but not
requesting to speak or participate in the roundtable, must register
online by 5 p.m. on July 9, 2012. Note that all meeting participants
will be able to listen to all the presentations and roundtable
discussion, as well as submit questions for the roundtable during the
meeting. Early registration is recommended because facilities are
limited, and therefore, FDA may also limit the number of participants
from
[[Page 27464]]
each organization. If time and space permit, onsite registration on the
day of the public workshop will be provided beginning at 7:30 a.m. If
you need special accommodations due to a disability, please contact
Cindy Garris (email: Cynthia.Garris@fda.hhs.gov or phone: 301-796-5861)
no later than July 9, 2012.
To register for the meeting, please visit the following Web site:
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences
(select this public workshop from the posted events list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Cindy Garris (email:
Cynthia.Garris@fda.hhs.gov or phone: 301-796-5861) for registration.
Registrants will receive confirmation once they have been accepted. You
will be notified if you are on a waiting list.
Streaming Webcast of Pediatric X-ray Imaging Meeting: This meeting
will also be webcast. Persons interested in viewing the webcast must
register online by 5 p.m. on July 9, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration, and will be sent connection
access information after July 12, 2012. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.
Requests for Oral Presentations: This meeting includes a public
comment session. During online registration you may indicate if you
wish to make an oral presentation during the public comment session,
and the topic you wish to address in your presentation. If you wish to
make a presentation during the public comment session, you must
register online by 5 p.m. on June 25, 2012. FDA has included topics and
questions for comment in this document. FDA will do its best to
accommodate requests to make public comment. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the public comment session. Following the close of
registration, FDA will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants. All requests to make oral
presentations must be made at the time of registration. Presentation
materials for selected oral presentations must be emailed to Thalia
Mills no later than July 9, 2012. No commercial or promotional material
will be permitted to be presented or distributed at the meeting.
Requests to Participate in Roundtable Discussion: This workshop
also includes a roundtable discussion. During online registration you
may indicate if you wish to participate in the roundtable discussion.
If you wish to request to participate, you must register online by 5
p.m. on June 25, 2012. The number of roundtable participants will be
limited, but all meeting participants will have the opportunity to view
and submit questions to the roundtable. A request to be a participant
does not guarantee a place in the roundtable discussion; participants
will be chosen to represent a broad variety of specialties.
Comments: FDA is holding this public meeting to obtain public
comment on the draft guidance ``Pediatric Information for X-ray Imaging
Device Premarket Notifications.'' Relevant issues include device design
features, labeling information, and testing specific to pediatric use.
The deadline for submitting comments related to this public meeting is
September 7, 2012.
Regardless of attendance at the public meeting, interested persons
may submit written or electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. It is only necessary to submit one set of
comments. Please identify comments with the docket number found in the
brackets in the heading of this notice. In addition, when responding to
specific questions as outlined in section IV of this document, please
identify the question that you are addressing. Received written
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday. Electronic comments can be
viewed in the public docket for this meeting at https://www.regulations.gov.
Transcripts: As soon as a transcript is available, it will be
accessible at https://www.regulations.gov. It may also be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
The development of this draft guidance is part of FDA's larger
Initiative to Reduce Unnecessary Radiation Exposure from Medical
Imaging (Ref. 1). While the benefit of a clinically appropriate x-ray
imaging exam far outweighs the risk, efforts should be made to minimize
this risk by reducing unnecessary exposure to ionizing radiation.
Ionizing radiation exposure to pediatric patients from medical imaging
procedures is of particular concern to the Agency for three reasons:
(1) Younger patients are more radiosensitive than adults (i.e., the
cancer risk per unit dose of ionizing radiation is higher) (Ref. 2);
(2) younger patients have a longer expected lifetime for the effects of
radiation exposure to manifest as cancer; and (3) use of equipment and
exposure settings designed for adults can result in excessive radiation
exposure for the smaller patient. The third point is of special concern
because many pediatric imaging exams are performed in facilities
lacking specialized expertise in pediatric imaging (Ref. 3).
On March 30 and 31, 2010, the Agency held a public meeting entitled
``Device Improvements to Reduce Unnecessary Radiation Exposure from
Medical Imaging'' (Ref. 4). The Agency asked whether manufacturers
should incorporate special provisions for pediatric patients,
particularly with regard to hardware and software features (Ref. 5).
Recommendations received by FDA, which apply to all general-use x-ray
imaging modalities, included making available pediatric protocols and
control settings, targeted instructions and educational materials
emphasizing pediatric dose reduction, quality assurance tools for
facilities emphasizing radiation dose management, and dose information
applicable to pediatric patients. Many of the recommendations from
pediatric experts focused on expanding the flexibility or range of
features already available on x-ray imaging devices, which may also
improve adult imaging for non-standard applications.
At the March 2010 meeting, experts commented that many radiological
devices are sold without the design features or labeling information
that
[[Page 27465]]
would help users optimize benefit (clinically-usable images) in
comparison to risk (radiation exposure) for pediatric imaging (Ref. 6).
Imaging professionals can safely use existing equipment that may not
have specific features or instructions for pediatric use by consulting
recommendations provided by the Alliance for Radiation Safety in
Pediatric Imaging (ARSPI) and other organizations. FDA has reviewed the
recommendations from ARSPI and believes they are appropriate. Because
of the special concerns about excessive exposure to radiation in
children, FDA believes that new x-ray imaging devices should be
demonstrated to be appropriate for pediatric use or use in pediatric
populations should be cautioned against. The end user can then make
more informed decisions about use of the device on pediatric patients.
FDA has therefore published a draft guidance entitled ``Pediatric
Information for X-ray Imaging Device Premarket Notifications'' and is
holding this public meeting to solicit public comment on the draft
guidance and broader radiation safety issues for use of x-ray imaging
devices on pediatric populations (Ref. 7).
In addition to drafting guidance, FDA is also engaged in
complementary outreach efforts aimed at providing imaging practitioners
with tools to reduce dose to pediatric patients. The Center for Devices
and Radiological Health and FDA's Critical Path Program funded two
contracts awarded in 2010 and 2011 to the Alliance for Radiation Safety
in Pediatric Imaging. The goal of the work is to develop improved
training material and instructions for pediatric digital radiography
(Ref. 8) and fluoroscopy (ongoing project). These materials will be
publicly available as a resource to both imaging facilities and device
manufacturers. FDA believes that engaging in such partnerships with
professional organizations helps ensure that the end user perspective
is incorporated into improved device features, instructions, and
training.
In order to inform health care professionals and the public, FDA
has also posted a new Web page on Pediatric X-ray Imaging (Ref. 9).
More information on the benefits and risks of x-ray imaging, as well as
radiation safety recommendations and resources specific to pediatric
patients, can be found on this Web page.
II. Draft Guidance: Pediatric Information for X-Ray Imaging Device
Premarket Notifications
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the draft guidance entitled ``Pediatric Information
for X-ray Imaging Device Premarket Notifications.'' This draft guidance
document provides industry and Agency staff with FDA's current thinking
on information that should be provided in premarket notifications for
x-ray imaging devices with indications for use in pediatric
populations. The Agency intends for this guidance to minimize
uncertainty during the premarket review process of 510(k)s for x-ray
imaging devices for pediatric use, to encourage the inclusion of
pediatric indications for use for x-ray imaging device premarket
notifications, and to provide recommendations on information to support
such indications. This draft guidance is not final nor is it in effect
at this time.
The draft guidance provides as follows: ``Manufacturers seeking
marketing clearance for a new x-ray imaging device with a pediatric
indication should provide data supporting the safety and effectiveness
of the device in pediatric populations. Manufacturers who seek
marketing clearance only for general indications or do not submit
adequate data to the FDA to support a pediatric indication for use for
x-ray imaging devices where pediatric use is likely should label their
x-ray imaging device with the statement `CAUTION: Not for use on
patients less than approximately [insert patient size (e.g., body part
thickness or height and weight appropriate to your device)].' as part
of the IFU statement. This statement should also be prominently
displayed on the device itself (e.g., control panel). The statement
should be revised depending on the size subgroups (see section 4 of the
draft guidance) for which manufacturers submit data.'' (Ref. 10).
This draft guidance applies only to complete x-ray imaging devices
that could be used on pediatric patients (e.g., x-ray computed
tomography, general and dental radiography, and diagnostic and
interventional fluoroscopy devices). The guidance is intended to be
used in conjunction with other guidance specific to particular x-ray
imaging modalities.
III. Purpose and Scope of the Meeting
Before the draft guidance ``Pediatric Information for X-ray Imaging
Device Premarket Notifications'' is finalized, FDA believes it is
crucial to receive public input from both industry and x-ray imaging
device users, particularly from those with pediatric expertise, on the
overall effort and on a number of specific questions (see section IV of
this document). In order to assist the public in providing targeted
comments, the FDA will present general background information on the
510(k) clearance process, the role of guidance, and the FDA's approach
to pediatric use of medical devices.
In addition to discussion of the guidance itself, another goal of
this meeting is to help identify issues relevant to radiation safety in
pediatric x-ray imaging that may benefit from standards development or
further research. FDA recognizes that a one-day meeting cannot cover
all the relevant issues; we are therefore soliciting ideas on how
device manufacturers, professional organizations, and FDA can best
follow up on the issues identified through a coordinated effort.
IV. Specific Questions for Discussion at the Public Meeting
In your submissions to the public docket and in oral presentations,
please consider the following questions. FDA will also consider your
comments on topics related to safe and effective use of x-ray imaging
devices on pediatric populations that are not covered by the questions
below or the draft guidance:
1. While radiation-induced cancer risk depends on a number of
factors including the patient's age, patient size (not age) is a major
factor in optimization of radiation exposure vs. image quality.
Although CDRH has defined the ``pediatric population'' as including
patients from birth to 21 years (Ref. 11), Section 4--``Pediatric
population'' of the draft guidance divides the pediatric population
into subgroups based on patient size rather than age. The intent of the
draft guidance is to extend the range of testing and labeling
information to small pediatric patients that may not be covered in
adult size ranges. Please provide comments on how pediatric subgroups
are covered in the guidance with respect to labeling information and
testing data. Specifically:
a. In the suggested language for the example caution statement to
appear in the labeling, FDA assumed that if a device is designed for a
broad range of adults, it will be capable of imaging patients over
about 50 kg in weight and 150 cm in height. In your experience, are
most general-use x-ray imaging devices adequately designed for patients
over this size? Is the overall wording of the suggested example caution
statement appropriate? The example statement referred to in this
question reads: ``CAUTION: This device is not intended for use on
patients less than approximately 50 kg (110 lb) in weight and 150 cm
(59 in) in height; these height and weight measurements
[[Page 27466]]
approximately correspond to that of an average 12 year old or a 5th
percentile U.S. adult female [Ref. 12]. Use of equipment and exposure
settings designed for adults of average size can result in excessive
radiation exposure for a smaller patient. Studies have shown that
pediatric patients may be more radiosensitive than adults (i.e. the
cancer risk per unit dose of ionizing radiation is higher), and so
unnecessary radiation exposure is of particular concern for pediatric
patients [Ref. 13].''
b. The draft guidance states that patient thickness is a more
appropriate metric than height and weight for describing populations
and gives references to literature data for thickness or circumference.
Which metric should be used in defining subgroups (e.g.,
anteroposterior and transverse body diameter or circumference)? Is it
appropriate to choose one body region (e.g., chest or abdomen) to
generally categorize population subgroups in terms of thickness or
circumference?
c. For tests that require phantoms, how many different sized
phantoms should be tested for a sponsor to demonstrate safe pediatric
use? Would a large adult-sized phantom and a small pediatric-sized
phantom be sufficient to demonstrate coverage of the entire range of
patient sizes? (Currently the draft guidance recommends at a minimum a
range of phantoms that represent birth-1 month, 1-year old, 5-year old,
12-year old, and adult sizes.)
d. For tests that do not involve phantoms, the document states
``that the range of settings and conditions for testing include those
that would normally be used during pediatric imaging'' (see Section 9
of the draft guidance). Do you have suggestions on how this range
should be covered? (e.g., would it be acceptable to perform tests with
settings matching those used only on the smallest and largest
patients?)
2. In the 510(k) premarket review process, FDA relies on the
concept of ``substantial equivalence'' to a predicate device to
demonstrate safe and effective use. The submitter of a 510(k) must
provide a statement of the intended use of the device. If the device
has specific indications for use that are different from those of the
predicate device, the 510(k) summary must contain an explanation as to
why the differences do not affect the safety and effectiveness of the
device when used as labeled (Ref. 14). Because many predicate x-ray
imaging devices that are on the market do not have a specific
indication for pediatric use, new x-ray imaging devices with a specific
indication for pediatric use will have to demonstrate that they are as
safe and effective as the predicate devices that are not indicated for
pediatric use. Especially with regard to sections 9 (Laboratory Image
Quality and Dose Assessment) and 10 (Clinical Image Quality Assessment)
in the draft guidance, FDA has outstanding questions regarding how to
demonstrate that an x-ray imaging device that has a specific indication
for pediatric use is as safe and effective as an x-ray imaging device
with only a general indication for use:
a. Can you think of a situation where phantom testing (objective
image quality and dose assessment) alone would be insufficient to
demonstrate safe and effective pediatric use and clinical data would be
necessary?
b. In those cases, would it be acceptable to provide images of
anthropomorphic phantoms instead of pediatric patients?
3. As currently written, the draft guidance document recommends
that any performance characteristics expected to change based on the
size of the object being imaged should be tested specifically for
pediatric use. FDA requests help identifying what these tests are,
i.e., which device features are size-dependent? (Tube current
modulation and/or automatic exposure control and data collection speed
are examples.) Because this guidance document is intended to cover all
x-ray imaging devices that could be used on pediatric patients, this
question relates specifically to x-ray computed tomography,
fluoroscopy, and general and dental radiography devices.
4. Table 3 in the Appendix of the draft guidance lists specific
pediatric issues currently addressed by applicable standards.
Establishing safe and effective use of x-ray imaging devices on
pediatric populations may involve special design features, labeling
(e.g. instructions for use) and training information, and performance
tests. The guidance covers these topics generally, but each modality
will have different issues. A variety of approaches for these topics
exist in the literature, but in many cases it may be beneficial if the
x-ray imaging community further developed prioritized, consensus
recommendations. FDA participates in development of national and
international standards. While FDA does not control the content of
these standards, standards liaisons can make recommendations. Do you
have specific recommendations for pediatric use issues that should be
covered by standards for performance features, testing, or labeling?
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. FDA White Paper, ``Initiative to Reduce Unnecessary Radiation
Exposure from Medical Imaging,'' available at https://www.fda.gov/RadiationEmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm, February 2010.
2. National Research Council of the National Academies, Committee to
Assess Health Risks from Exposure to Low Levels of Ionizing
Radiation, ``Health Risks from Exposure to Low Levels of Ionizing
Radiation: BEIR VII Phase,'' National Academy of Sciences (National
Academies Press, 2006).
3. For example, the following study found that non-pediatric focused
emergency departments made up 89.4 percent of emergency department
visits associated with CT (computed tomography) in children: Larson,
D.B., et al., ``Rising Use of CT in Child Visits to the Emergency
Department in the United States, 1995-2008,'' Radiology, 259(3),
793-801, 2011.
4. FDA Public Meeting: Device Improvements to Reduce Unnecessary
Radiation Exposure from Medical Imaging, March 30-31, 2010, agenda
and transcripts, available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm, public docket
submissions, available at https://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=FDA-2010-N-0080.
5. The Federal Register notice (75 FR 8375-8377) lists all the
questions asked at the meeting, February 24, 2010, available at
https://edocket.access.gpo.gov/2010/2010-3674.htm.
6. The principles of radiation protection in medicine, including
``optimization'' are described in ``Radiological Protection in
Medicine, International Commission on Radiological Protection,''
Annals of the ICRP, 37(6), 2007. Optimization of radiation exposure
for x-ray imaging means the following: Examinations should use
techniques that are adjusted to administer the lowest radiation dose
that yields an image quality adequate for diagnosis or intervention
(i.e., radiation doses should be ``As Low as Reasonably Achievable''
(ALARA)).
7. The FDA draft guidance entitled ``Pediatric Information for X-ray
Imaging Device Premarket Notifications,'' is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm.
8. The Image Gently/FDA Digital Radiography Safety Checklist and
accompanying documents are available at https://www.pedrad.org/
associations/
[[Page 27467]]
5364/ig/index.cfm?page=775.
9. The FDA Web page for information on Pediatric X-ray Imaging, is
available at https://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm.
10. Under section 513(i)(1)(E)(i) of the Federal Food, Drug, and
Cosmetic Act, when determining that a device is substantially
equivalent to a predicate device, FDA may require limitations in
device labeling about off-label use of the device when ``there is a
reasonable likelihood'' of such use, and if ``such use could cause
harm.'' Such determinations are made on a case by case basis and
other requirements must be met, including a consultation between FDA
and the 510(k) submitter, before such limitations can be required.
FDA's policy on when a device may be found ``substantially
equivalent with limitations'' is discussed further in the guidance
entitled ``Determination of Intended Use for 510(k) Devices;
Guidance for CDRH Staff (Update to K98-1),'' available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082162.htm, December 3, 2003.
11. The FDA guidance entitled ``Premarket Assessment of Pediatric
Medical Devices,'' is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089742.pdf, May 14, 2004.
12. McDowell, M.A., C.D. Fryar, C.L. Ogden, and K. M. Flegal,
``Anthropomorphic Reference Data for Children and Adults: United
States, 2003-2006,'' National Health Statistics Reports, vol. 10, 1-
48, available at https://www.cdc.gov/nchs/data/nhsr/nhsr010.pdf,
October 22, 2008.
13. National Research Council of the National Academies, Committee
to Assess Health Risks from Exposure to Low Levels of Ionizing
Radiation, ``Health Risks from Exposure to Low Levels of Ionizing
Radiation: BEIR VII Phase,'' National Academy of Sciences (National
Academies Press), is available at https://www.nap.edu/openbook.php?isbn=030909156X, 2006.
14. See 21 CFR 807.92.
Dated: May 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11262 Filed 5-9-12; 8:45 am]
BILLING CODE 4160-01-P
