<html>
<head>
<title>Federal Register, Volume 91 Issue 1 (Friday, January 2, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 1 (Friday, January 2, 2026)]
[Notices]
[Pages 145-148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-24155]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 146]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19
& Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked
the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by the Authorization holder. The revocations, which
include an explanation of the reasons for each revocation, are
reprinted at the end of this document.
DATES: The revocation of the Authorizations for the Pfizer Inc.'s
Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 &
Flu Home Test were effective as of October 22, 2025.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Policy, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5441, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request or include a fax
number to which the revocations may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a
toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, radiological, or nuclear agent or agents. Among
other things, section 564 of the FD&C Act allows FDA to authorize the
use of an unapproved medical product or an unapproved use of an
approved medical product in certain situations.
On November 22, 2022, FDA issued the Authorization to Lucira
Health, Inc. for the Lucira COVID-19 & Flu Test, subject to the terms
of the Authorization.\1\ Notice of the issuance of this Authorization
was published in the Federal Register on January 23, 2023 (88 FR 3995),
as required by section 564(h)(1) of the FD&C Act.
---------------------------------------------------------------------------
\1\ Ownership of the EUA for the Lucira COVID-19 & Flu Test was
transferred from Lucira Health Inc. to Pfizer Inc., on June 15,
2023, and the name was changed to Lucira by Pfizer COVID-19 & Flu
Test.
---------------------------------------------------------------------------
On February 24, 2023, FDA issued the Authorization to Lucira
Health, Inc. for the Lucira COVID-19 & Flu Home Test, subject to the
terms of the Authorization.\2\ Notice of the issuance of this
Authorization was published in the Federal Register on March 10, 2023
(88 FR 15051), as required by section 564(h)(1) of the FD&C Act.
---------------------------------------------------------------------------
\2\ Ownership of the EUA for the Lucira COVID-19 & Flu Home Test
was transferred from Lucira Health Inc. to Pfizer Inc., on June 15,
2023, and the name was changed to Lucira by Pfizer COVID-19 & Flu
Home Test.
---------------------------------------------------------------------------
Subsequent updates to the Authorizations were made available on
FDA's website. The authorization of a device for emergency use under
section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the
FD&C Act, be revoked when the criteria under section 564(c) of the FD&C
Act for issuance of such authorization are no longer met (section
564(g)(2)(B) of the FD&C Act), or other circumstances make such
revocation appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorizations Revocation Requests
In a request received by FDA on October 10, 2025, Pfizer Inc.
requested the revocation of, and on October 22, 2025, FDA revoked, the
Authorization for the Pfizer Inc.'s Lucira by Pfizer COVID-19 & Flu
Test. Pfizer Inc. notified FDA as the date of the letter there is no
viable Lucira by Pfizer COVID-19 & Flu Test reagents remaining in the
United States, and requested FDA revoke the Pfizer Inc.'s Lucira by
Pfizer COVID-19 & Flu Test. FDA has determined that it is appropriate
to protect the public health or safety to revoke this Authorization.
In a request received by FDA on October 10, 2025, Pfizer Inc.,
requested the revocation of, and on October 22, 2025, FDA revoked, the
Authorization for the Pfizer Inc.'s Lucira by Pfizer COVID-19 & Flu
Home Test. Pfizer Inc. notified FDA that as the date of the letter
there is no viable Lucira by Pfizer COVID-19 & Flu Home Test reagents
remaining in the United States, and requested FDA revoke the Pfizer
Inc.'s Lucira by Pfizer COVID-19 & Flu Home Test. FDA has determined
that it is appropriate to protect the public health or safety to revoke
this Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA for Pfizer Inc.'s Lucira by Pfizer COVID-19 & Flu
Test and Lucira by Pfizer COVID-19 & Flu Home Test. The revocations in
their entirety follow and provide an explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[[Page 147]]
[GRAPHIC] [TIFF OMITTED] TN02JA26.000
[[Page 148]]
[GRAPHIC] [TIFF OMITTED] TN02JA26.001
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-24155 Filed 12-31-25; 8:45 am]
BILLING CODE 4164-01-C
</pre></body>
</html>
Document
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfize...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
91 FR 145
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability,” thefederalregister.org (January 2, 2026), https://thefederalregister.org/documents/2025-24155/revocation-of-two-authorizations-of-emergency-use-of-in-vitro-diagnostic-devices-for-detection-and-or-diagnosis-of-covid.