Document ID: FDA-2020-D-0987-0072
Agency: fda
Document Type: Notice
Title: Policy for Coronavirus Disease - 2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability
Posted Date: 2022-09-28T04:00Z

[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58803-58806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0987]

Policy for Coronavirus Disease--2019 Tests During the Public 
Health Emergency (Revised); Immediately in Effect Guidance for 
Commercial Manufacturers 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 document related to the 
Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) 
entitled ``Policy for Coronavirus Disease--2019 Tests During the Public 
Health Emergency (Revised).'' FDA is issuing this guidance to provide 
FDA's revised enforcement policies and review priorities regarding 
certain novel coronavirus (COVID-19) tests for the duration of the 
public health emergency. Rapid detection of COVID-19 cases in the 
United States requires wide availability of testing to control the 
spread of this highly contagious infection. This document supersedes 
``Policy for Coronavirus Disease--2019 Tests During the Public Health 
Emergency (Revised)'' issued November 15, 2021. The guidance identified 
in this notice addresses issues related to the COVID-19 PHE and has 
been issued in accordance with the expedited process FDA announced in 
the Federal Register of March 25, 2020, for making available to the 
public COVID-19-related guidances. This guidance has been implemented 
without prior comment, but it remains subject to comment in accordance 
with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on September 28, 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.

[[Page 58804]]

     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-2020-D-0987 for ``Policy for Coronavirus Disease--2019 Tests During 
the Public Health Emergency (Revised).'' 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 Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for a single hard copy of the guidance 
document entitled ``Policy for Coronavirus Disease--2019 Tests During 
the Public Health Emergency (Revised)'' 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance entitled 
``Policy for Coronavirus Disease--2019 Tests During the Public Health 
Emergency (Revised),'' which supersedes the guidance of the same title 
issued November 15, 2021. FDA is issuing this guidance to provide FDA's 
updated enforcement policies and review priorities regarding certain 
novel coronavirus (COVID-19) tests for the duration of the public 
health emergency. Rapid detection of COVID-19 cases in the United 
States requires wide availability of testing to control the spread of 
this highly contagious infection.
    Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360bbb-3), the FDA Commissioner may authorize the use 
of unapproved medical products, or unapproved uses of approved medical 
products, in certain emergency circumstances, after the HHS Secretary 
has made a declaration of emergency or threat justifying authorization 
of emergency use, to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by chemical, biological, 
radiological, and nuclear threat agents when certain criteria are met 
(emergency use authorization (EUA)). As of August 15, 2022, FDA has 
authorized under EUA more than 439 tests for COVID-19, including more 
than 354 diagnostic and 85 serology or other immune response tests. 
Further, two molecular diagnostic COVID-19 tests have been granted 
marketing authorization through the traditional device premarket review 
pathways.
    In the context of a public health emergency involving pandemic 
infectious disease, it is critically important that tests are validated 
because false results not only can negatively impact the individual 
patient but also can have a broad public health impact. False positive 
results for diagnostic tests, for example, can lead to unnecessary 
quarantine and potential further spread when presumed positive 
individuals are quarantined together, wasted contact tracing and 
testing resources, and delay in accurate diagnosis and appropriate 
treatment for the individual. False negative results can lead to lack 
of appropriate treatment for the individual and further spread of the 
disease.
    FDA has continued to closely monitor the COVID-19 testing landscape 
and believes it is appropriate to update its policies to reflect the 
current needs of the pandemic. As explained throughout this updated 
guidance, FDA intends to review the EUA requests for a smaller subset 
of tests. Traditional marketing pathways remain available to all 
developers and FDA encourages developers of tests that fall outside the 
scope of the priorities outlined in this updated guidance to pursue 
those routes. In sum, FDA has revised this guidance to update the types 
of COVID-19 tests for which the Agency intends to review EUA requests, 
to discuss the use of the traditional premarket review pathways for 
other types of COVID-19 tests for which the Agency does not intend to 
review EUA requests, and to make minor updates to the enforcement 
policies.
    On January 31, 2020, as a result of confirmed cases of COVID-19, 
and after consultation with public health officials as necessary, the 
Secretary of Health and Human Services (HHS), pursuant to the authority 
under section 319 of the Public Health Service Act (42 U.S.C. 247d), 
determined that a PHE exists and has existed since January 27, 2020, 
nationwide.\1\ On March 13, 2020, there was a Presidential declaration 
that the COVID-19 outbreak in the United States constitutes a national 
emergency, beginning March 1, 2020.\2\
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    \1\ Secretary of Health and Human Services, ``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.
    \2\ Proclamation on Declaring a National Emergency Concerning 
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), 
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there 
was a Presidential Declaration continuing the national emergency 
concerning the COVID-19 pandemic beyond March 1, 2021. See 
Continuation of the National Emergency Concerning the Coronavirus 
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at 
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.

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[[Page 58805]]

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March 
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced various procedures for 
making available FDA guidances related to the COVID-19 PHE. The March 
25, 2020, notice stated that due to the need to act quickly and 
efficiently to respond to the COVID-19 PHE and to allow FDA to rapidly 
disseminate Agency recommendations and policies related to COVID-19 to 
industry, FDA staff, and other stakeholders, prior public participation 
would not be feasible or appropriate before FDA implemented COVID-19-
related guidances. FDA will continue to issue COVID-19-related 
guidances for immediate implementation without prior public comment 
(see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 
Sec.  10.115(g)(2)). The guidances are available on FDA's web pages 
entitled ``COVID-19-Related Guidance Documents for Industry, FDA Staff, 
and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and ``Search for 
FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.) Although this guidance has 
been implemented immediately without prior comment, FDA will consider 
all comments received and revise the guidance as appropriate (see Sec.  
10.115(g)(3)).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA. 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
OMB under the Paperwork Reduction Act of 1995 (PRA). The collections of 
information in the following FDA regulations and guidances have been 
approved by OMB as listed in the table below. This guidance also 
contains a new collection of information not approved under a current 
collection. The new collection of information has been granted a public 
health emergency (PHE) waiver from the PRA by the Department of Health 
and Human Services (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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                                                                                       New collection covered by
        21 CFR part or guidance                    Topic             OMB control No.         PHE PRA waiver
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Emergency Use Authorization of Medical   Emergency Use                      0910-0595  .........................
 Products and Related Authorities;        Authorization.
 Guidance for Industry and Other
 Stakeholders.
``Administrative Procedures for CLIA     Administrative Procedures          0910-0607  .........................
 Categorization; Guidance for Industry    for Clinical Laboratory
 and Food and Drug Administration         Improvement Amendments
 Staff'' and ``Recommendations for        of 1988 Categorization.
 Clinical Laboratory Improvement
 Amendments of 1988 (CLIA) Waiver
 Applications for Manufacturers of In
 Vitro Diagnostic Devices; Guidance for
 Industry and Food and Drug
 Administration Staff''.
803....................................  Medical devices; medical           0910-0437  .........................
                                          device reporting;
                                          manufacturer reporting,
                                          importer reporting, user
                                          facility reporting,
                                          distributor reporting.
807, subpart E.........................  Premarket notification...          0910-0120  .........................
814, subparts A through E..............  Premarket approval.......          0910-0231  .........................
860, subpart D.........................  De Novo classification             0910-0844  .........................
                                          process.
``Requests for Feedback and Meetings     Q-submissions; pre-                0910-0756  .........................
 for Medical Device Submissions: The Q-   submissions.
 Submission Program''.
                                                                                       Voluntary templates to
                                                                                        facilitate the
                                                                                        preparation and
                                                                                        submission of an
                                                                                        Emergency Use
                                                                                        Authorization request
                                                                                        for various types of
                                                                                        COVID-19 tests.
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III. Electronic Access

    Persons with access to the internet may obtain the guidance at:
     FDA web page entitled ``Guidance Documents (Medical 
Devices and Radiation-Emitting Products)'' available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products;
     FDA web page entitled ``COVID-19-Related Guidance 
Documents for Industry, FDA Staff, and Other Stakeholders,'' available 
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/
covid-19-

[[Page 58806]]

related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance 
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: September 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20828 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P