Attention: Clinical Laboratory Professionals

Please share the following with:

Medical Director, Laboratory Services
Lab Manager(s)

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.

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