Revocation of Three 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 Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. 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.

Affected frameworks & controls

• HIPAA 164.312(a)(1) — Access Control — unique user identification and emergency access.