10/09/2020: Lab Alert: FDA Suspends Review of EUA Requests for Laboratory-Developed Tests for SARS-CoV-2

CDC's Laboratory Outreach Communication System (LOCS)

The Laboratory Outreach Communication System (LOCS) issued an update to this message on 11/17/2021. Please refer to the updated LOCS message for the most current information.

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

The U.S. Department of Health and Human Services (HHS) recently announced that the U.S. Food and Drug Administration (FDA) will not require premarket review of Laboratory-Developed Tests (LDTs) for SARS-CoV-2. In alignment with this announcement, FDA will not review Emergency Use Authorization (EUA) requests for any LDTs at this time.

On Wednesday, October 7, FDA posted a new frequently asked question (FAQ) that clarifies the agency’s priorities for reviewing EUA submissions for SARS-CoV-2 testing, including the statement that “FDA is declining to review EUA requests for LDTs at this time.” Read the FDA FAQs here.

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)