FDA Will Loosen COVID LDT Regs When EUA Declaration Ends

FDA signals in guidance released Friday (March 24) that laboratory-developed tests used for COVID-19 may not need to undergo premarket review once the so-called 564 declaration that gives FDA authority to issue emergency use authorizations during a public health emergency comes to an end. FDA since November 2021 has required all newly offered COVID-19 tests, including LDTs, to have either EUA or traditional marketing authorization before being offered to consumers. The policy is different from FDA’s approach to LDTs more...