07/28/2020: Lab Update: FDA Issues COVID-19 Testing and Policy Updates

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Lab Update: FDA Issues COVID-19 Testing and Policy Updates

Level: Laboratory Update

The U.S. Food and Drug Administration (FDA) recently issued Emergency Use Authorizations (EUA) for SARS-CoV-2 diagnostic tests that includes the pooling of specimens, and the first EUA for the screening of asymptomatic individuals – see FDA’s list of In Vitro Diagnostics EUAs. In addition, FDA issued guidance on transport media, revoked the serology umbrella EUA, and updated its frequently asked questions (FAQs) to include information about SARS-CoV-2 diagnostic tests and sample pooling. See below for details:

  • On July 21, FDA revoked the Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2. Any test that was once eligible for consideration under the umbrella EUA will now be considered for an individual EUA.
  • Also on July 21, FDA published a new FDA Voices blog post, which highlights the agency’s recent efforts to facilitate the availability of safe and accurate SARS-CoV-2 diagnostic tests.
  • On July 22, FDA updated the FAQs on Testing for SARS-CoV-2 webpage to include a list of commercial manufacturers of diagnostic tests that have been removed from the notification list. FDA now has “do not use” lists for laboratory developers of diagnostic tests, commercial manufacturers of diagnostic tests, and commercial manufacturers of serological tests.

Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)