[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SUMMARY: FDA is announcing the following public meeting on the draft 
guidance ``Pediatric Information for X-ray Imaging Device Premarket 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feedback on the draft guidance and to help identify issues relevant to 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

[[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 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