Revocation of EUA202920, Lucira COVID-19 All-In-One Test Kit — Pfizer Inc. (April 2, 2025)

Summary

A letter dated April 2, 2025 from the U.S. Food and Drug Administration to Pfizer Inc. revoking EUA202920 for the Lucira COVID-19 All-In-One Test Kit. It responds to Pfizer's request in a letter dated March 14, 2025, and recites that the EUA was issued on November 17, 2020 and later amended and reissued. The letter states that Pfizer indicated it did not distribute the authorized product and that FDA understands no viable test kit reagents are in distribution in the United States. Citing section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), FDA revokes the authorization and states that notice will be published in the Federal Register. It closes with the signature block of Ellen J. Flannery, Deputy Center Director for Policy, Center for Devices and Radiological Health.

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Full text

                                           April 2, 2025

Elizabeth Mauro
Director, Global Regulatory Science
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Re: Revocation of EUA202920

Dear Elizabeth Mauro:
This letter is in response to the request from Pfizer Inc., in letter dated March 14, 2025, that the
U.S. Food and Drug Administration (FDA) revoke the EUA for the Lucira COVID-19 All-In-
One Test Kit issued on November 17, 2020, amended on September 23, 2021, and July 28, 2022,
and revised and reissued on November 15, 2022, and June 14, 2023. Pfizer Inc. indicated that
they did not distribute the authorized product and requested that the EUA be revoked. FDA
understands that as of the date of this letter there are no viable Lucira COVID-19 All-In-One
Test Kit reagents in distribution in the United States.

The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because Pfizer Inc. has requested that FDA revoke the
EUA for the 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. Accordingly, FDA hereby revokes
EUA202920 for the Lucira COVID-19 All-In-One Test Kit, pursuant to section 564(g)(2)(C) of
the Act. As of the date of this letter, the Lucira COVID-19 All-In-One Test Kit is no longer
authorized for emergency use by FDA.

Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(1)
of the Act.

                                              Sincerely,



                                              __________________________
                                              Ellen J. Flannery, J.D.
                                              Deputy Center Director for Policy
                                              Director, Office of Policy
                                              Center for Devices and Radiological Health
                                              Food and Drug Administration


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www.fda.gov