[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51201-51204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2049]


Medical X-Ray Imaging Devices Conformance With International 
Electrotechnical Commission Standards; Draft Guidance for Industry and 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the availability of the draft guidance entitled ``Medical X-Ray Imaging 
Devices Conformance With IEC Standards.'' This draft guidance describes 
FDA's policy regarding the regulation of medical x-ray imaging 
equipment that are subject to requirements in the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to 
medical devices and electronic products. The draft guidance also 
provides recommendations to industry on how to comply with the 
applicable requirements. This draft guidance is not final nor is it in 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 on 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 1, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 51202]]

Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-2049 for ``Medical X-Ray Imaging Devices Conformance With 
IEC Standards.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 draft guidance document entitled 
``Medical X-Ray Imaging Devices Conformance With IEC Standards'' 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: Robert Sauer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5628, Silver Spring, MD 20993-0002, 301-796-3580.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft guidance describes FDA's policy regarding the regulation 
of medical x-ray imaging equipment that are subject to requirements in 
the FD&C Act and FDA's regulations that apply to medical devices and 
electronic products. In the draft guidance, FDA is seeking to harmonize 
performance standards prescribed under section 534 of subchapter C 
(Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 
U.S.C. 360kk) with International Electrotechnical Commission (IEC) 
standards, where appropriate, to help to ensure streamlined regulatory 
review of submissions for these products. The draft guidance also 
provides recommendations to industry on how to comply with the 
applicable requirements. FDA believes industry conformance to certain 
IEC standards would provide the same level of or improved protection of 
the public health and safety from electronic radiation as certain EPRC 
regulatory standards. FDA also believes conformance to certain IEC 
standards would be sufficient to meet the 510(k) premarket notification 
requirement for certain devices. FDA review of related radiological 
health and safety data in premarket submissions, as opposed to EPRC 
product reports, would maintain or improve device safety while 
consolidating the information manufacturers submit to FDA.

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 current thinking of FDA on ``Medical X-
Ray Imaging Devices Conformance With IEC Standards.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. Persons unable to download an electronic 
copy of ``Medical X-Ray Imaging Devices Conformance With IEC 
Standards'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1400014 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval

[[Page 51203]]

from the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
revision of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Reporting and Recordkeeping for Electronic Products--General 
Requirements--21 CFR parts 1002 through 1050--OMB Control Number 0910-
0025--Revision

    The draft guidance describes FDA's policy regarding the regulation 
of medical x-ray imaging equipment that are subject to FDA's 
regulations that apply to medical devices and electronic products. FDA 
believes industry conformance to certain IEC standards would be 
sufficient to meet the 510(k) premarket notification requirement for 
certain of these devices. FDA review of related radiological health and 
safety data in premarket submissions, as opposed to EPRC product 
reports, would maintain or improve device safety while consolidating 
the information manufacturers submit to FDA. Currently, information 
regarding the IEC standards is submitted as part of the premarket 
notification (approved under OMB control number 0910-0120). Under the 
draft guidance, if finalized, respondents may choose to submit 
declarations of conformity with certain IEC standards--in either a 
510(k) or if no 510(k) is submitted in an Abbreviated Report under 21 
CFR 1002.12(e)--instead of submitting EPRC reports for certain devices 
in the circumstances described in the draft guidance.
    Based on an analysis of recent submissions from Fiscal Year (FY) 
2015, approximately 93 percent of manufacturers of Class II medical x-
ray imaging devices, including CT, fluoroscopy, and stationary x-ray 
systems, claimed conformance to an applicable IEC standard. 
Accordingly, we believe that the majority of manufacturers of Class II 
medical x-ray imaging systems would choose to continue to submit 
declarations of conformity to these IEC standards and not submit EPRC 
product reports, supplemental reports, and annual reports under the 
guidance. The other 7 percent of manufacturers of Class II medical x-
ray imaging devices and likely a subset of these 93 percent may choose 
to submit product reports, supplemental reports, and annual reports.
    In FY 2015, there were 22 Class II product reports and 13 Class I 
product reports for x-ray imaging devices submitted to FDA. Therefore, 
we expect a reduction of 34 respondents to the estimated burden for the 
product reports, supplemental reports, and annual report information 
collections in table 1 of this document. Because 13 of these x-ray 
imaging devices are 510(k)-exempt, Class I devices, we would expect an 
increase of 13 respondents to the estimated burden for the information 
collection related to Abbreviated Reports in table 1 of this document 
(as these manufacturers would be submitting their declarations of 
conformity in these reports), which corresponds to an expected 
reduction of 13 respondents to the estimated burden for the product 
reports, supplemental reports, and annual reports information 
collections in table 1 of this document. This equals an overall 
reduction of 1,395 hours in OMB control number 0910-0025.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Reporting Burden \1,2,3\
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                                                                                             Number of                        Average
        Activity/21 CFR section                      FDA form                Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k)........  3626--Diagnostic x-ray.........           1,466             1.1           1,613              24          38,712
                                         3627--CT x-ray.................
                                         3639--Cabinet x-ray............
                                         3632--Laser....................  ..............
                                         3640--Laser light show.........  ..............
                                         3630--Sunlamp..................  ..............
                                         3646--Mercury vapor lamp.......  ..............
                                         3644--Ultrasonic therapy.......  ..............
                                         3659--TV.......................  ..............
                                         3660--Microwave oven...........  ..............
                                         3801--UV lamps.................  ..............
Product safety or testing changes--      ...............................             966             1.5           1,449             0.5             725
 1002.11(a)-(b).
Abbreviated reports--1002.12...........  3629--General abbreviated                    73               2             146               5             730
                                          report.
                                         3661--X-ray tables, etc........
                                         3662--Cephalometric device.....  ..............
                                         3663--Microwave products (non-   ..............
                                          oven).

[[Page 51204]]

 
Annual reports--1002.13(a)-(b).........  3628--General..................           1,466               1           1,466              18          26,388
                                         3634--TV.......................
                                         3638--Diagnostic x-ray.........
                                         3641--Cabinet x-ray............  ..............
                                         3643--Microwave oven...........  ..............
                                         3636--Laser....................  ..............
                                         3631--Sunlamp..................  ..............
                                         3647--Mercury vapor lamp.......  ..............
                                         3645--Ultrasonic therapy.......  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
  include all ICs approved under OMB control number 0910-0025. The draft guidance, if finalized, would be a reduction to the burden estimate for these
  ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to avoid
  confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the draft
  guidance.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\3\ Totals may not sum due to rounding.

    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA. 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; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073. The collections of information in 21 CFR 
parts 1002 through 1050 are approved under OMB control number 0910-
0025.

    Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18300 Filed 8-2-16; 8:45 am]
 BILLING CODE 4164-01-P