90 FR 102 pgs. 22727-22732 - Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 90Number: 102Pages: 22727 - 22732
Pages: 22727, 22728, 22729, 22730, 22731, 22732Docket number: [Docket No. FDA-2022-N-0150]
FR document: [FR Doc. 2025-09678 Filed 5-28-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
Footnotes:
1 ?Ownership of the EUA for the Lucira COVID-19 All-In-One Test Kit was transferred from Lucira Health, Inc. to Pfizer Inc.
On April 9, 2021, FDA issued the Authorization to Lucira Health, Inc. for the Lucira CHECKvIT 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.
Footnotes:
2 ?Ownership of the EUA for the Lucira CHECK-IT COVID-19 Test Kit was transferred from Lucira Health, Inc. to Pfizer Inc.
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
[top] 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
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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