CDC LOCS Lab Alert: FDA Suspends Review of EUA Requests for Laboratory-Developed Tests for SARS-CoV-2

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:

• HHS FAQs on Laboratory-Developed Tests
• Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
• COVID-19 Information for Laboratories
• Frequently Asked Questions about COVID-19 for Laboratories
• CDC COVID-19 Website
• Clinical Laboratory COVID-19 Response Calls
• CDC Laboratory Outreach Communication System (LOCS)
• 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 LOCS@cdc.gov.

This Lab Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.