[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18144-18146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1149]


Transition Plan for Medical Devices Issued Emergency Use 
Authorizations Related to Coronavirus Disease 2019 (COVID-19); 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 Issued Emergency Use Authorizations (EUAs) Related to 
Coronavirus Disease 2019 (COVID-19).'' 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 pandemic 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 this transition process 
with respect to devices issued EUAs related to COVID-19, including 
recommendations regarding submitting a marketing submission, as 
applicable, and taking other actions with respect to these devices.

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 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-1149 for ``Transition Plan for Medical Devices Issued 
Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 
(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

[[Page 18145]]

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 Issued Emergency Use 
Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)'' 
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: Jacqueline Gertz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 240-
402-9677.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, the Secretary of Health and Human Services 
(the Secretary) issued a declaration of a public health emergency (PHE) 
related to COVID-19 in accordance with section 319 of the Public Health 
Service Act (section 319 PHE) (42 U.S.C. 247d) and mobilized the 
Operating Divisions of the Department of Health and Human Services 
(HHS).\1\ Pursuant to section 564 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), on February 4, 2020, the 
Secretary determined that there is a PHE that has significant potential 
to affect national security or the health and security of U.S. citizens 
living abroad, and that involves the SARS-CoV-2 virus that causes 
COVID-19. On the basis of such determination, the Secretary declared on 
that same day, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
the SARS-CoV-2 virus that causes COVID-19 (85 FR 7316). Based on the 
February 4, 2020, determination, the Secretary issued two more 
declarations justifying emergency uses related to devices: on March 2, 
2020, for certain personal respiratory protective devices (85 FR 
13907), and on March 24, 2020, for devices, including alternative 
products used as devices (85 FR 17335). On March 15, 2023, the 
Secretary amended the February 4, 2020 determination to recognize the 
fact that there is ``a public health emergency, or a significant 
potential for a public health emergency, that affects, or has a 
significant potential to affect, national security or the health and 
security of United States citizens living abroad . . .'' and that 
involves the SARS-CoV-2 virus that causes COVID-19 (emphasis added) (88 
FR 16644).
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    \1\ Secretary of HHS, Determination that a Public Health 
Emergency Exists (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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    Section 564 of the FD&C Act authorizes FDA, after the Secretary has 
made a declaration of emergency or threat justifying authorization of 
emergency use, to authorize the emergency use of an unapproved product 
or an unapproved use of an approved product for certain emergency 
circumstances. FDA may issue an EUA to allow a product to be used to 
diagnose, treat, or prevent a serious or life-threatening disease or 
condition referenced in the EUA declaration, when the statutory 
criteria are met, including FDA's determination that, based on the 
totality of scientific evidence, the product may be effective for such 
use, the known and potential benefits outweigh the known and potential 
risks for such use, and that there are no adequate, approved, and 
available alternatives.
    An EUA issued under section 564 of the FD&C Act remains in effect 
for the duration of the relevant EUA declaration, unless the EUA is 
revoked because the criteria for issuance are no longer met or 
revocation is appropriate to protect public health or safety (see 
section 564(f) through (g) of the FD&C Act).
    Given the magnitude of the response to the COVID-19 pandemic, 
including the number of devices issued EUAs, FDA recognizes that 
stakeholders may need time to adjust after the termination of the 
device EUA declarations to help to ensure an orderly and transparent 
transition to ``normal operations.'' The Agency is issuing this 
guidance to describe FDA's general recommendations for this transition 
process with respect to devices issued EUAs related to COVID-19, 
including recommendations regarding submitting a marketing submission, 
as applicable, and taking other actions with respect to these devices. 
FDA is concurrently issuing a companion transition guidance to describe 
FDA's recommendations for devices that fall within certain enforcement 
policies issued during the section 319 PHE related to COVID-19.
    This guidance applies to devices that have been issued an EUA under 
section 564 of the FD&C Act on the basis of a device EUA declaration 
related to COVID-19. This guidance does not apply to devices for which 
FDA has revoked the EUA under section 564(g)(2)(B) through (C) of the 
FD&C Act because the criteria under section 564(c) of the FD&C Act were 
no longer met or because other circumstances made such revocation 
appropriate to protect the public health or safety.
    HHS intends to publish the advance notice of termination of each 
EUA declaration pertaining to devices in the Federal Register 180 days 
before the day on which the EUA declaration is terminated. The advance 
notice of termination of each device EUA declaration may occur 
simultaneously or at different times, depending on whether the 
circumstances underlying such declarations continue to exist (section 
564(b)(2)(A) of the FD&C Act).
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 23, 2021 (86 FR 72978). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including revising the recommendation for interim 
labeling during the time when the device EUA declaration has been 
terminated and a manufacturer's marketing submission for a device is 
under FDA review, providing clarity on 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, in vitro diagnostics, and example scenarios.
    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 the ``Transition Plan for Medical Devices 
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus 
Disease 2019 (COVID-19).'' 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.

[[Page 18146]]

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. 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 
Issued Emergency Use Authorizations (EUAs) Related to Coronavirus 
Disease 2019 (COVID-19)'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00020042 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA 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 (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.

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                                        Another guidance referenced in    OMB control    New collection covered
 CFR cite referenced in this guidance            this guidance              No(s).          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''.
                                        ``Administrative Procedures          0910-0607
                                         for CLIA Categorization'' and
                                         ``Recommendations for
                                         Clinical Laboratory
                                         Improvement Amendments of
                                         1988 (CLIA) Waiver
                                         Applications for
                                         Manufacturers of In Vitro
                                         Diagnostic Devices--Guidance
                                         for Industry and FDA 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. 2023-06292 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P


