07/28/2020: Lab Update: FDA Issues COVID-19 Testing and Policy Updates
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 EUAsexternal icon. 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 20, FDA issued COVID-19 Transport Media Policyexternal icon guidance to expand the availability of transport media used for testing certain clinical specimens during the COVID-19 public health emergency.
- FDA also published new FAQs on Viral Transport Media During COVID-19external icon and updated its Testing Supply FAQsexternal icon.
- On July 21, FDA revoked the Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2external icon. 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 Voicesexternal icon 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-2external icon 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.
- Frequently Asked Questions about Coronavirus for Laboratories
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC’s Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- CDC COVID-19 website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up.
If you have any questions, please contact us at LOCS@cdc.gov.
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)