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

Publication Date: Oct 10, 2020

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.

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