Federal Register, Volume 90 Issue 102 (Thursday, May 29, 2025)

[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22727-22732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Four 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.

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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 COVID-19 All-In-
One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories 
for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and 
Nuclein, LLC (merged with Molecular Diagnostics Inc.) for the DASH 
SARS-CoV-2/S 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 Authorization for the Pfizer Inc.'s Lucira 
COVID-19 All-In-One Test and Lucira CHECK-IT COVID-19 Test Kit was 
effective as of April 2, 2025, MAWD Laboratories' MAWD Laboratories 
SARS-CoV-2 Dual Target by RT-PCR was effective as of April 2, 2025, and 
Nuclein, LLC's (following merger with Molecular Diagnostics Inc.) DASH 
SARS-CoV-2/S Test was effective as of April 3, 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. 
5431, 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 17, 2020, FDA issued the Authorization to Lucira 
Health, Inc. for the Lucira COVID-19 All-In-One Test Kit, subject to 
the terms of the Authorization.\1\ Notice of the issuance of this 
Authorization was published in the Federal Register on April 23, 2021 
(86 FR 21749), as required by section 564(h)(1) of the FD&C Act.
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    \1\ Ownership of the EUA for the Lucira COVID-19 All-In-One Test 
Kit was transferred from Lucira Health, Inc. to Pfizer Inc.
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    On April 9, 2021, FDA issued the Authorization to Lucira Health, 
Inc. for the Lucira CHECK[radic]IT COVID-19 Test Kit, subject to the 
terms of the Authorization.\2\ Notice of the issuance of this 
Authorization was published in the Federal Register on July 23, 2021 
(86 FR 39040), as required by section 564(h)(1) of the FD&C Act.
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    \2\ Ownership of the EUA for the Lucira CHECK-IT COVID-19 Test 
Kit was transferred from Lucira Health, Inc. to Pfizer Inc.
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    On October 13, 2023, FDA issued the Authorization to MAWD 
Laboratories for the MAWD Laboratories' SARS-CoV-2 Dual Target by RT-
PCR, subject to the terms of the Authorization. Notice of the issuance 
of this Authorization was published in the Federal Register on January 
25, 2024 (89 FR 4952), as required by section 564(h)(1) of the FD&C 
Act.
    On March 15, 2022, FDA issued the Authorization to Minute Molecular 
Diagnostics, Inc. (merged with Nuclein, LLC) for the DASH SARS-CoV-2/S 
Test, subject to the terms of the Authorization. Notice of the issuance 
of this Authorization was published in the Federal Register on July 22, 
2022 (87 FR 43877), as required by section 564(h)(1) of the FD&C Act.
    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 March 14, 2025, Pfizer Inc. 
requested the revocation of, and on April 2, 2025, FDA revoked, the 
Authorization for the Pfizer Inc.'s Lucira COVID-19 All-In-One Test 
Kit. Pfizer Inc. notified FDA that it did not distribute the Pfizer 
Inc.'s

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Lucira COVID-19 All-In-One Test Kit, and requested FDA revoke the 
Pfizer Inc.'s Lucira COVID-19 All-In-One Test Kit. 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 March 14, 2025, Pfizer Inc., 
requested the revocation of, and on April 2, 2025, FDA revoked, the 
Authorization for the Pfizer Inc.'s Lucira CHECK-IT COVID-19 Test Kit. 
Pfizer Inc. notified FDA that it did not distribute the Pfizer Inc.'s 
Lucira CHECK-IT COVID-19 Test Kit, and requested FDA revoke the Pfizer 
Inc.'s Lucira CHECK-IT COVID-19 Test Kit. 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 March 17, 2025, MAWD Laboratories 
requested the revocation of, and on April 2, 2025, FDA revoked, the 
Authorization for the MAWD Laboratories' MAWD Laboratories SARS-CoV-2 
Dual Target by RT-PCR. MAWD Laboratories notified FDA that it had 
discontinued use of the MAWD Laboratories SARS-CoV-2 Dual Target by RT-
PCR as of April 2, 2025, and requested FDA revoke the MAWD 
Laboratories' MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR. 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 March 17, 2025, Nuclein, LLC 
(following merger with Minute Molecular Diagnostics, Inc.), requested 
the revocation of, and on April 3, 2025, FDA revoked, the Authorization 
for the Nuclein, LLC's DASH SARS-CoV-2/S Test. Nuclein, LLC notified 
FDA that it had ceased manufacture of the authorized Nuclein, LLC's 
DASH SARS-CoV-2/S Test as of January 1, 2025, and requested FDA revoke 
the Nuclein, LLC's DASH SARS-CoV-2/S 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 https://www.regulations.gov/.

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 Pfizer Inc.'s Lucira CHECK-IT COVID-19 Test Kit and 
Lucira COVID-19 All-In-One Test Kit, MAWD Laboratories' MAWD 
Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC's DASH 
SARS-CoV-2/S 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.
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    Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09678 Filed 5-28-25; 8:45 am]
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