[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56248-56250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Pediatric Information for 
X-ray Imaging Device Premarket Notifications.'' This guidance document 
outlines FDA's current thinking on information that should be provided 
in premarket notification submissions for x-ray imaging devices that 
are indicated for pediatric populations or general use x-ray imaging 
devices for which considerable pediatric application is anticipated. 
FDA intends for this guidance to minimize uncertainty during the 
premarket review process of premarket notification submissions for x-
ray imaging devices for pediatric use to encourage the inclusion of 
pediatric indications for use for x-ray imaging device premarket 
notification submissions and to provide recommendations on information 
to support such indications. Both new devices and modifications of 
existing x-ray imaging devices that require submission of a new 
premarket notification are included within the scope of this guidance 
document, regardless of whether the device is a complete x-ray imaging 
system, a component part of an x-ray imaging device, or an accessory 
(e.g., detectors and software).

DATES: The announcement of the guidance is published in the Federal 
Register on November 28, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-

[[Page 56249]]

2012-D-0384 for ``Pediatric Information for X-ray Imaging Device 
Premarket Notifications.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Pediatric Information for X-ray Imaging Device Premarket 
Notifications'' to the Office of the Center Director, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Laurel Burk, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4268, Silver Spring, MD 20993-0002, 301-796-5933.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance document outlines the current thinking of FDA 
regarding information that should be provided in premarket notification 
submissions (510(k)s) and device labeling for x-ray imaging devices 
that are indicated for pediatric populations or general use x-ray 
imaging devices for which considerable pediatric application is 
anticipated. General use x-ray imaging devices typically neither 
include nor exclude specific populations in the indications for use and 
may be expected to be used in any population. Because a large 
percentage of the hundreds of millions of x-ray examinations performed 
annually in the United States are exams of pediatric patients, FDA 
expects that most general use x-ray imaging devices will be used for a 
considerable quantity of pediatric examinations unless a device's 
design precludes use in smaller sized patients. This guidance is 
intended to enhance clarity regarding the premarket review process of 
510(k)s for x-ray imaging devices, to encourage the inclusion of 
pediatric indications for use for x-ray imaging device 510(k)s, and to 
provide recommendations regarding labeling, including the instructions 
for use.
    In February 2010, FDA launched an ``Initiative to Reduce 
Unnecessary Radiation Exposure from Medical Imaging'' (https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm); and on March 30 and 31, 2010 
(75 FR 8375, February 24, 2010), the Agency held a public meeting 
entitled ``Device Improvements to Reduce Unnecessary Radiation Exposure 
from Medical Imaging'' (https://www.federalregister.gov/documents/2010/02/24/2010-3674/device-improvements-to-reduce-unnecessary-radiation-exposure-from-medical-imaging-public-meeting). At the meeting, FDA 
sought advice on ``steps that manufacturers of computerized tomography 
(CT) 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.
    In the Federal Register of May 10, 2012 (77 FR 27461), the Agency 
announced the issuance of the draft guidance entitled ``Pediatric 
Information for X-ray Imaging Device Premarket Notifications'' and 
interested persons were invited to comment by September 7, 2012. On 
July 16, 2012 (77 FR 27463, May 10, 2012), the Agency held a public 
meeting entitled ``Device Improvements for Pediatric X-ray Imaging'' 
(https://www.regulations.gov/document?D=FDA-2012-N-0385-0002) where FDA 
also solicited public feedback on the draft of this guidance. FDA has 
considered the comments received and has incorporated changes suggested 
by the comments, as appropriate. In addition, FDA requested help in 
identifying issues relevant to radiation safety in pediatric x-ray 
imaging that might benefit from standards development or further 
research at this workshop. FDA requested specific comments on technical 
device design and pediatric safety questions. Since the 2012 meeting, 
many recommended device design improvements have been incorporated into 
FDA-recognized consensus standards, and others are under consideration 
for future revisions of such standards.
    In 2014, the Agency issued a revised general pediatric guidance 
entitled ``Premarket Assessment of Pediatric Medical Devices.'' The 
guidance, which applies to all devices, defines pediatric 
subpopulations and the general information that should be provided for

[[Page 56250]]

different types of premarket submissions for devices intended for use 
in pediatric populations.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on pediatric information for x-ray imaging 
device 510(k)s. It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Pediatric 
Information for X-ray Imaging Device Premarket Notifications'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1771 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 
(PRA) (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. The collections of 
information in the guidance document ``Requests for Feedback on Medical 
Device Submissions: The Pre-Submission Program and Meetings with Food 
and Drug Administration Staff'' have been approved under OMB control 
number 0910-0756. 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).)

    Dated: November 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25632 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P