Document ID: FDA-2016-D-2049-0012
Agency: fda
Document Type: Notice
Title: Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Guidance for Industry and
Food and Drug Administration Staff; Availability
Posted Date: 2019-05-08T04:00Z

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20145-20146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09405]

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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; 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 a final guidance for industry entitled ``Medical X-
Ray Imaging Devices Conformance with IEC Standards.'' This guidance 
describes FDA's policy regarding the regulation of medical x-ray 
imaging equipment that is subject to the Federal Food, Drug and 
Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical 
devices and electronic products.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2019.

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-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 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 
``Medical X-Ray Imaging Devices Conformance with IEC Standards'' to the 
Office of Policy, 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:

[[Page 20146]]

I. Background

    This guidance describes FDA's policy regarding the regulation of 
medical x-ray imaging equipment that is subject to the FD&C Act and 
FDA's regulations that apply to medical devices and electronic 
products. In this guidance, FDA is seeking to harmonize performance 
standards prescribed pursuant to section 534 of Subchapter C 
(Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 
U.S.C. 360(kk)) with International Electrotechnical Commission (IEC) 
standards, where appropriate, to help to ensure streamlined regulatory 
review of submissions for these products. The guidance also provides 
recommendations to industry on how to comply with the applicable 
requirements. FDA has determined that industry conformance to certain 
IEC standards would provide, at a minimum, the same level of protection 
of the public health and safety from electronic radiation as certain 
EPRC regulatory standards. In addition, due to the recent publication 
of a proposed rule (84 FR 12147) on April 1, 2019, that would, if 
finalized, eliminate the reporting requirements for x-ray imaging 
devices, FDA determined that the proposed policy outlined in section 4 
of the draft guidance, which stated that x-ray imaging devices that 
conform to IEC standards would be considered to have met the EPRC 
reporting requirements, should be removed from the guidance. This 
decision was made to avoid the confusion inherent in establishing an 
interim procedure that would shortly be superseded by the final rule. 
However, as stated in section V. of the guidance, FDA believes that 
submission of a declaration of conformity to the appropriate standards, 
and model identification as required by 21 CFR 1002.10(a) and (b), in a 
product report, would be sufficient to meet the requirements of a 
product report under 21 CFR 1002.10, thus reducing duplication.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of August 3, 2016 (81 FR 51201). FDA 
revised the guidance as appropriate in response to the comments.

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 ``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. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Persons 
unable to download an electronic copy of ``Medical X-Ray Imaging 
Devices Conformance with IEC Standards'' may send an email request to 
CDRH-Guidance@fda.hhs.gov 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

    In the Federal Register of August 3, 2016 (81 FR 51201), we 
requested comments on the revision of OMB control number 0910-0025, 
``Reporting and Recordkeeping for Electronic Products--General 
Requirements,'' to adjust the annual reporting burden consistent with 
the policy in the draft guidance pertaining to reports. However, 
because this final guidance does not include this policy pertaining to 
reports (see the Background section), we have determined that the 
guidance no longer necessitates revisions to OMB control number 0910-
0025.
    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations have been approved by OMB as listed in 
the following table:

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                                                            OMB control
          21 CFR part                     Topic                 No.
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807, subpart E.................  Premarket Notification.       0910-0120
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
1002 through 1050..............  Reporting and                 0910-0025
                                  Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
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    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09405 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P