FDA gives EUA to additional tests and issues policy on diagnostic testing for COVID-19

Since March 13, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19. As of the morning of March 17, six tests now have received EUAs.

The FDA also issued guidance to provide a policy to help accelerate the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency