[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