HHS, FDA Clash Over Voluntary Requests For COVID-19 LDT EUAs

By Kelly Lienhard / October 26, 2020 at 7:10 PM
Updated Story HHS and FDA are once again clashing over laboratory-developed tests. An HHS official tells Inside Health Policy that labs can still voluntarily seek emergency use authorization of COVID-19 LDTs to get liability protection even though the department axed FDA’s regulation of the tests in August, but FDA told labs on Oct. 7 it would no longer accept voluntarily submitted EUAs for the tests. The American Clinical Laboratory Association says labs want the option of voluntarily...


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