09/27/2022: Lab Advisory: FDA Updates COVID-19 Test Policy and FAQs

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Laboratory and Testing Professionals

Level: Laboratory Advisory

On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 test policy to address public health testing needs during this phase of the COVID-19 public health emergency. The FDA is revising its COVID-19 test policy to encourage most COVID-19 test developers to pursue a traditional premarket review pathway for their tests rather than emergency use authorization.

Please review the revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency and updated FAQs on Testing for SARS-CoV-2 and share this message with your networks.

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The Laboratory Outreach Communication System

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

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

Centers for Disease Control and Prevention (CDC)