FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections

It’s the latest salvo in the push-and-pull between the FDA and the HHS over LDTs

 
• By Shawn M. Schmitt

The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.

Pipette adding fluid to one of several test tubes

The push-and-pull between the US Department of Health and Human Services and the Food and Drug Administration over laboratory developed tests took a surprising turn today when the agency declared that it will no longer grant emergency use authorizations (EUAs) for LDTs.

That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the Public Readiness and...

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