[Federal Register Volume 77, Number 91 (Thursday, May 10, 2012)]
[Notices]
[Pages 27461-27463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0384]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Pediatric Information for X-Ray Imaging Device Premarket 
Notifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Pediatric Information for 
X-ray Imaging Device Premarket Notifications.'' This draft guidance 
document outlines FDA's current thinking on information that should be

[[Page 27462]]

provided in premarket notifications for x-ray imaging devices with 
indications for use in pediatric populations. FDA 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 This draft guidance applies only to 
complete x-ray imaging devices that could be used on pediatric 
patients. This draft guidance is not final nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 7, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Pediatric Information for X-ray Imaging 
Device Premarket Notifications'' to the Division of Small 
Manufacturers, International and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Thalia Mills, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, rm. 4527, Silver Spring, MD 20993-0002, 301-796-6641.

SUPPLEMENTARY INFORMATION:

I. Background

    Currently, most x-ray imaging devices are marketed with a general 
indication for use (IFU) statement. Many general use x-ray imaging 
devices have neither addressed the unique issues associated with 
pediatric use nor contain labeling specific for use on pediatric 
patients, even though many (if not all) of these devices are used or 
could be used to image pediatric patients.
    Exposure to ionizing radiation is of particular concern in 
pediatric patients for three reasons: (1) Younger patients are more 
radiosensitive than adults (i.e., the cancer risk per unit dose of 
ionizing radiation is higher for younger patients) (Ref. 1); (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 adult use 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. 2).
    In 2004, the Agency issued general pediatric guidance entitled 
``Premarket Assessment of Pediatric Medical Devices'' (Ref. 3). The 
guidance, which applies to all devices, defines pediatric 
subpopulations and the general information that should be provided for 
different types of premarket submissions for devices intended for use 
in pediatric populations.
    In February 2010, FDA launched an ``Initiative to Reduce 
Unnecessary Radiation Exposure from Medical Imaging'' (Ref. 4)'' and on 
March 30 and 31, 2010, the Agency held a public meeting entitled 
``Device Improvements to Reduce Unnecessary Radiation Exposure from 
Medical Imaging'' (Ref. 5). At the meeting, FDA sought advice on 
``steps that manufacturers of CT (computerized tomography) and 
fluoroscopic devices could take to reduce unnecessary radiation 
exposure through improved product design, enhanced labeling, or 
improved instructions and training for equipment use and quality 
assurance at medical imaging facilities.'' The Agency asked whether 
manufacturers should incorporate special provisions for pediatric 
patients, particularly with regard to hardware and software features. 
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 nonstandard applications (Ref. 5).
    Experts have commented that many radiological devices are sold 
without the design features or labeling information that would help 
users optimize benefit (clinically-usable images) in comparison to risk 
(radiation exposure) for pediatric imaging. 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 the 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.
    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 be revised depending on the size subgroups (see 
section 4 of the draft guidance) for which manufacturers submit data 
and be prominently displayed on the device itself (e.g., control 
panel).
    This draft guidance applies only to complete x-ray imaging devices 
that could be used on pediatric patients. This document does not apply 
to imaging equipment sold as components or accessories (such as tube-
housing assemblies, tables, or detectors). This guidance should be used 
in conjunction with other guidance specific to your type of x-ray 
imaging device (e.g., x-ray CT, general radiography and dental 
radiography, and diagnostic and interventional fluoroscopy devices) 
that addresses how you should meet premarket notification (510(k)) 
submission requirements under 21 CFR part 807. This guidance 
supplements

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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.

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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Pediatric Information for X-ray Imaging Device Premarket 
Notifications,'' you may either send an email request to 
[email protected] 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 ``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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm, 2004.
4. The FDA initiative entitled ``Initiative to Reduce Unnecessary 
Radiation Exposure from Medical Imaging,'' available at http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/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 http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/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]
BILLING CODE 4160-01-P