🧪FDA Revokes Emergency Use Authorizations for COVID-19 Tests
Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The revocation of Emergency Use Authorizations (EUAs) impacts biotechnology and pharmaceutical companies involved in COVID-19 testing and diagnostics. Business owners must ensure compliance with FDA regulations and be aware of shifts in the market due to the discontinuation of these tests.