🏥FDA Revokes EUA for Cepheid COVID-19 Diagnostic Device
Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
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 for revocation, is reprinted at the end of this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The revocation of the Emergency Use Authorization (EUA) for the Cepheid Xpert Xpress SARS-CoV-2 test affects compliance and regulatory requirements for businesses in the medical device sector. Companies using this test may need to find alternative diagnostics, impacting sales, operations, and financial planning.