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