FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: REVOCATION OF AUTHORIZATION OF EMERGENCY USE OF IN VITRO DIAGNOSTIC DEVICE FOR DETECTION AND/OR DIAGNOSIS OF COVID-19; AVAILABILITY

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability.

The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Cepheid for the Xpert Xpress SARS-CoV-2 test. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reason...