Document ID: FDA-2015-D-3787-0024
Agency: fda
Document Type: Notice
Title: Electromagnetic Compatibility of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2022-06-06T04:00Z

[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Pages 34275-34277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Electromagnetic Compatibility of Medical Devices; 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

[[Page 34276]]

announcing the availability of a final guidance entitled 
``Electromagnetic Compatibility (EMC) of Medical Devices.'' FDA has 
developed this guidance document to recommend 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), De Novo request, and certain biologics license applications 
(BLAs) and investigational new drug (IND) applications to demonstrate 
electromagnetic compatibility (EMC) for electrically powered medical 
devices and medical devices with electrical or electronic functions. 
This guidance provides 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,'' which was published July 11, 
2016 (2016 EMC guidance).

DATES: The announcement of the guidance is published in the Federal 
Register on June 6, 2022.

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-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 guidance document entitled 
``Electromagnetic Compatibility (EMC) of Medical Devices'' to the 
Office of Policy, 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. 62, 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 recommend information 
that should be provided in a premarket submission (i.e., PMA, HDE, 
510(k), IDE, De Novo request, and certain BLAs and IND applications) 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 guidance, when final, will replace the FDA guidance entitled 
``Information to Support a Claim of Electromagnetic

[[Page 34277]]

Compatibility (EMC) of Electrically-Powered Medical Devices'' (2016 EMC 
guidance), which was published July 11, 2016. This guidance provides 
additional technical information to address the recommendations in the 
2016 EMC guidance.
    FDA recognizes and anticipates that the Agency and industry may 
need up to 1 year to perform activities to operationalize the policies 
within the guidance, only for in vitro diagnostic products. Because 
this guidance generally reflects current practice for the assessment of 
EMC for other device types, but some activities to fully operationalize 
the policies are needed (e.g., updates to eSTAR \1\), FDA intends to 
implement this guidance 60 days after issuance for device types within 
the scope of this guidance, excluding in vitro diagnostic products. If 
new information regarding electromagnetic compatibility as outlined in 
this guidance is not included in a premarket submission for an in vitro 
diagnostic received by FDA before or up to 1 year after the publication 
of this guidance or for other device types within the scope of this 
guidance before or up to 60 days after the publication of this 
guidance, FDA does not generally intend to request such information 
during the review of the submission. FDA does, however, intend to 
review any such information if submitted.
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    \1\ Available at https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program.
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    A notice of availability of the draft guidance appeared in the 
Federal Register of November 17, 2020 (85 FR 73276). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarification of scope; addressing the use 
of IEC 60601-1-2:2020, which was published after the draft guidance was 
issued; and adding a transition period to facilitate the implementation 
of the 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 EMC 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 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 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 [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1400057 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new 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 have been approved by 
OMB as listed in the following table:

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               21 CFR part                                       Topic                          OMB Control No.
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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
860, subpart D..........................  De Novo classification process.....................          0910-0844
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); Quality          0910-0073
                                           System (QS) Regulation.
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    Dated: May 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12099 Filed 6-3-22; 8:45 am]
BILLING CODE 4164-01-P