[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]
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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.
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SUMMARY: FDA is announcing the following public meeting on the draft
guidance ``Pediatric Information for X-ray Imaging Device Premarket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feedback on the draft guidance and to help identify issues relevant to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 http://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
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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:
http://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 http://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 http://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 http://www.regulations.gov.
Transcripts: As soon as a transcript is available, it will be
accessible at http://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
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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 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
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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 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 http://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 http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm, public docket
submissions, available at http://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
http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm.
8. The Image Gently/FDA Digital Radiography Safety Checklist and
accompanying documents are available at http://www.pedrad.org/
associations/
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5364/ig/index.cfm?page=775.
9. The FDA Web page for information on Pediatric X-ray Imaging, is
available at http://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 http://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 http://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 http://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 http://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