[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18153-18156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-D-1118 and FDA-2020-D-1138]


Transition Plan for Medical Devices That Fall Within Enforcement 
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency; Guidance for Industry, Other Stakeholders, 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 entitled ``Transition Plan for 
Medical Devices That Fall Within Enforcement Policies Issued During the 
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA 
recognizes that it will take time for device manufacturers, device 
distributors, healthcare facilities, healthcare providers, patients, 
consumers, and FDA to adjust from policies adopted and operations 
implemented during the COVID-19 public health emergency (PHE) to 
``normal operations.'' To provide a clear policy for all stakeholders 
and FDA staff, the Agency is issuing this guidance to describe FDA's 
general recommendations for a phased transition process with respect to 
devices that fall within certain enforcement policies issued during the 
COVID-19 PHE declared by the Secretary of Health and Human Services 
(the Secretary) under the Public Health Service Act (PHS Act), 
including recommendations regarding submitting a marketing submission, 
as applicable, and taking other actions with respect to these devices. 
This guidance applies to devices that fall within enforcement policies 
in guidances included in List 1 of this guidance. The phased transition 
process outlined in this guidance will begin on the ``implementation 
date.'' The implementation date is the day the PHE expires or 45 days 
after the finalization of this guidance, whichever comes later. Because 
the COVID-19 section 319 PHE declaration is anticipated to expire at 
least 45 days after the finalization of this guidance, or May 11, 2023, 
the implementation date is that date. The guidances in List 1 of this 
guidance will no longer be in effect after the 180-day transition 
period ends.

DATES: The announcement of the guidance is published in the Federal 
Register on March 27, 2023.

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

[[Page 18154]]

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-2021-D-1118 for ``Transition Plan for Medical Devices That Fall 
Within Enforcement Policies Issued During the Coronavirus Disease 2019 
(COVID-19) Public Health Emergency'' or the Docket No. FDA-2020-D-1138 
for ``Center for Devices and Radiological Health (CDRH): COVID-19.'' 
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 
``Transition Plan for Medical Devices That Fall Within Enforcement 
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency'' 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. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Ryan Ortega, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4618, Silver Spring, MD 20993-0002, 240-402-2303.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, the Secretary issued a declaration of a PHE 
related to COVID-19 in accordance with section 319 of the PHS Act 
(section 319PHE) (42 U.S.C. 247d) and mobilized the Operating Divisions 
of the Department of Health and Human Services (HHS).\1\ FDA issued 
various guidance documents that describe enforcement policies for 
certain devices that are intended to support the emergency response to 
the COVID-19 pandemic.
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    \1\ Secretary of HHS, Determination That a Public Health 
Emergency Exists (hereinafter referred to as ``section 319 PHE 
declaration'') (originally issued on January 31, 2020, and 
subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. On February 9, 2023, the 
Secretary renewed the section 319 PHE declaration related to COVID-
19, effective February 11, 2023. The section 319 PHE declaration 
related to COVID-19 is anticipated to expire at the end of the day 
on May 11, 2023. See the HHS ``Fact Sheet: COVID-19 Public Health 
Emergency Transition Roadmap,'' (February 9, 2023), available at 
https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.
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    Given the magnitude of the response to the COVID-19 pandemic, FDA 
recognizes that a phased approach may help to facilitate an orderly and 
transparent transition to normal operations. The Agency is issuing this 
guidance to describe FDA's general recommendations for a phased 
transition process with respect to devices that fall within certain 
enforcement policies issued during the COVID-19 PHE, including 
recommendations regarding submitting a marketing submission, as 
applicable, and taking other actions with respect to these devices. 
This guidance applies to devices that fall within the enforcement 
policies described in List 1 of the guidance. FDA is concurrently 
issuing a companion transition guidance to describe FDA's 
recommendations for devices issued Emergency Use Authorizations related 
to COVID-19.
    As described in this guidance, a 180-day transition period will 
begin on the implementation date. The implementation date is the date 
the COVID-19 section 319 PHE expires or 45 days after the finalization 
of this guidance, whichever comes later. Because the COVID-19 section 
319 PHE declaration is anticipated to expire at least 45 days after the 
finalization of this guidance, or on May 11, 2023, the implementation 
date is that date. FDA believes the phased approach over the course of 
180 days following the implementation date as set forth in this 
guidance can help foster compliance with applicable legal requirements 
once the relevant enforcement policies are no longer in effect.
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 23, 2021 (86 FR 72973). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including providing clarity on the recommendations 
regarding physical and/or electronic copies of updated labeling, and 
adding clarifications regarding use of real-world evidence in marketing 
submissions, interactions with FDA, collaboration with stakeholders on 
the transition process, and revisions to example scenarios.

[[Page 18155]]

    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 ``Transition Plan for Medical Devices That 
Fall Within Enforcement Policies Issued During the Coronavirus Disease 
2019 (COVID-19) Public Health Emergency.'' 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. Guidances Identified in List 1 of This Guidance

    As part of FDA's commitment to support continuity and response 
efforts to the COVID-19 pandemic, the transition plan outlined in this 
guidance takes into account that the guidances in List 1 of this 
guidance will no longer be in effect after the 180-day transition 
period ends, or after November 7, 2023.
    Generally, the guidances that set forth COVID-19-related 
enforcement policies for certain devices initially stated that they 
were intended to remain in effect only for the duration of the section 
319 PHE declaration. As FDA announced in the Federal Register on March 
13, 2023,\2\ many of these guidance documents--the guidances in List 
1--have been revised to state that they are intended to continue in 
effect for 180 days after the section 319 PHE declaration expires 
unless a different intended duration is set forth in the finalized 
version of this guidance. A different intended duration is not being 
set forth in this guidance. The implementation date is the date the 
section 319 PHE declaration expires, and the guidances are intended to 
continue in effect for 180 days after that date.
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    \2\ See ``Guidance Documents Related to Coronavirus Disease 2019 
(COVID-19)'' (88 FR 15417), available at https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19.
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    In finalizing this guidance, FDA added the following guidances to 
List 1: ``Enforcement Policy for Viral Transport Media During the 
Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)'' 
\3\ and ``Enforcement Policy for Face Shields, Surgical Masks, and 
Respirators During the Coronavirus Disease (COVID-19) Public Health 
Emergency.'' \4\ These guidances were added to help facilitate an 
appropriate transition period for these devices away from the policies 
adopted and operations implemented during the COVID-19 PHE to normal 
operations. FDA removed the following guidances from List 1: 
``Enforcement Policy for the Quality Standards of the Mammography 
Quality Standards Act During the COVID-19 Public Health Emergency,'' 
\5\ ``Enforcement Policy for Non-Invasive Remote Monitoring Devices 
Used to Support Patient Monitoring During the Coronavirus Disease 2019 
(COVID-19) Public Health Emergency (Revised),'' \6\ ``Enforcement 
Policy for Face Masks and Barrier Face Coverings During the Coronavirus 
Disease 2019 (COVID-19) Public Health Emergency,'' 7 8 and 
``Enforcement Policy for Clinical Electronic Thermometers During the 
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' \9\ FDA 
has removed these guidances from List 1 because: (1) the policy in the 
guidance should not continue in effect beyond the expiration of the 
COVID-19 PHE or (2) the guidance was extended beyond the expiration of 
the COVID-19 PHE and FDA intends to retain the policy with appropriate 
changes. See the Federal Register notice entitled ``Guidance Documents 
Related to Coronavirus Disease 2019 (COVID-19).'' \10\
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    \3\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health.
    \4\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19. 
Bifurcation of the ``Enforcement Policy for Face Masks, Barrier Face 
Coverings, Face Shields, Surgical Masks, and Respirators During the 
COVID-19 Public Health Emergency (Revised)'' guidance was announced 
in the Federal Register notice on March 13, 2023. The guidance 
relating to face shields, surgical masks, and respirators is on List 
1, and the guidance related to face masks and barrier face 
coverings, as noted below, is outside the scope of this guidance.
    \5\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-public-health.
    \6\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during.
    \7\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public.
    \8\ See footnote 4.
    \9\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public.
    \10\ See footnote 2.
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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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Transition Plan for Medical Devices 
That Fall Within Enforcement Policies Issued During the Coronavirus 
Disease 2019 (COVID-19) Public Health Emergency'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number GUI00021011 and complete 
title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
(PRA). The collections of information in the following FDA regulations 
and guidance have been approved by OMB as listed in the table below.
    This guidance also contains new collections of information not 
approved under a current collection. These new collections of 
information have been granted a PHE waiver from the PRA by HHS on March 
19, 2020, under section 319(f) of the PHS Act. Information concerning 
the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

[[Page 18156]]



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                                        Another guidance referenced in    OMB control    New collection covered
              21 CFR part                        this guidance                No.           by PHE PRA waiver
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                                        ``Emergency Use Authorization        0910-0595
                                         of Medical Products and
                                         Related Authorities; Guidance
                                         for Industry and Other
                                         Stakeholders''.
                                        ``Requests for Feedback and          0910-0756
                                         Meetings for Medical Device
                                         Submissions: The Q-Submission
                                         Program Guidance for Industry
                                         and Food and Drug
                                         Administration Staff''.
800, 801, and 809.....................  ..............................       0910-0485
803...................................  ..............................       0910-0437
806...................................  ..............................       0910-0359
807, subparts A through D.............  ..............................       0910-0625
807, subpart E........................  ..............................       0910-0120
812...................................  ..............................       0910-0078
814, subparts A through E.............  ..............................       0910-0231
814, subpart H........................  ..............................       0910-0332
820...................................  ..............................       0910-0073
830 and 801.20........................  ..............................       0910-0720
860, subpart D........................  ..............................       0910-0844
                                                                                        Notification of Intent.
                                                                                        Transition
                                                                                         Implementation Plan.
                                                                                        Labeling Mitigation for
                                                                                         Certain Reusable
                                                                                         Devices.
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    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06291 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P