Health Law Daily Wrap Up, ADMINISTRATION OF THE FDC ACT—NOTICES: FDA revokes EUAs for multiple COVID-19 tests approved during the COVID-19 pandemic, (May 30, 2025)

By WK Editorial Staff

Having concluded that the criteria for revocation of the Authorizations 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 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 (Notice, 90 Fed. Reg. 22727 (May 29, 2025)).

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.

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