[Federal Register Volume 85, Number 222 (Tuesday, November 17, 2020)]
[Notices]
[Pages 73276-73277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25306]



[[Page 73276]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3787]


Electromagnetic Compatibility of Medical Devices; Draft Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Electromagnetic 
Compatibility (EMC) of Medical Devices.'' FDA has developed this 
guidance document to describe relevant information that should be 
provided in a premarket submission (i.e., premarket approval 
application (PMA), humanitarian device exemption (HDE), premarket 
notification (510(k)) submission, investigational device exemption 
(IDE), and De Novo request) to support a claim of electromagnetic 
compatibility for electrically powered medical devices and medical 
devices with electrical or electronic functions. This draft guidance is 
not intended to change current policy, but to provide specific 
technical information to address the recommendations originally 
described in the guidance entitled ``Information to Support a Claim of 
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical 
Devices'' published July 11, 2016 (2016 EMC guidance). This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by January 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2015-D-3787 for ``Electromagnetic Compatibility (EMC) of Medical 
Devices.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 draft guidance document entitled 
``Electromagnetic Compatibility (EMC) of Medical Devices'' 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; or to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Seth J. Seidman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1108, Silver Spring, MD 20993-0002, 301-
796-2477; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has developed this guidance document to describe relevant 
information that should be provided in a premarket submission (i.e., 
PMA, HDE

[[Page 73277]]

application, 510(k) submission, IDE application, and De Novo requests) 
to demonstrate EMC for electrically powered medical devices and medical 
devices with electrical or electronic functions. Typically, the review 
of EMC information in a submission is based on the risk associated with 
malfunction or degradation of the medical device under consideration, 
where malfunction or degradation could be caused by inadequate EMC. The 
review is also based on the use of appropriate consensus standards. 
This draft guidance is intended to replace ``Information to Support a 
Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered 
Medical Devices'' published July 11, 2016. This draft guidance is not 
intended to change current policy, but to provide specific technical 
information to address the recommendations in the 2016 EMC 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 the 
electromagnetic compatibility of medical devices. 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.

II. 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 Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or from the Center for 
Biologics Evaluation and Research at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at 
https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download 
an electronic copy of ``Electromagnetic Compatibility (EMC) of Medical 
Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please include the complete 
title and the document number 16040 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidance have been 
approved by OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                                                                                                    OMB control
            21 CFR part or guidance                                   Topic                             No.
----------------------------------------------------------------------------------------------------------------
807, subpart E................................  Premarket notification..........................       0910-0120
814, subparts A through E.....................  Premarket approval..............................       0910-0231
814, subpart H................................  Humanitarian Device Exemption...................       0910-0332
812...........................................  Investigational Device Exemption................       0910-0078
``De Novo Classification Process (Evaluation    De Novo classification process..................       0910-0844
 of Automatic Class III Designation)''.
800, 801, and 809.............................  Medical Device Labeling Regulations.............       0910-0485
803...........................................  Medical Devices; Medical Device Reporting;             0910-0437
                                                 Manufacturer reporting, importer reporting,
                                                 user facility reporting, distributor reporting.
820...........................................  Current Good Manufacturing Practice (CGMP);            0910-0073
                                                 Quality System (QS) Regulation.
----------------------------------------------------------------------------------------------------------------


    Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25306 Filed 11-16-20; 8:45 am]
BILLING CODE 4164-01-P


