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
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.
