As E&C Dems press Azar to justify LDT deregulatory decision . . .

FDA Will No Longer Review Labs’ EUA Requests For COVID-19 LDTs

By Kelly Lienhard / October 8, 2020 at 4:12 PM
FDA on Wednesday (Oct. 7) quietly updated its COVID-19 testing frequently asked questions webpage to say it will no longer review emergency use authorization requests for laboratory-developed tests for COVID-19. In August, HHS blocked FDA from regulating all LDTs, including COVID-19 LDTs, but said at the time that labs could still voluntarily request EUAs in order to get liability protection for COVID-19 tests. FDA’s pivot came as House Energy & Commerce Committee Democratic leaders on Wednesday asked how FDA could...

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