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FDA Issues New COVID-19 EUA Requirements After HHS Restores Agency’s LDT Oversight Role

 
• By Elizabeth Orr

A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.

FDA entrance sign 2016

The US Department of Health and Human Services (HHS) has withdrawn a controversial 2020 dictate that blocked the Food and Drug Administration from regulating laboratory-developed tests (LDTs), allowing the agency to impose new requirements on submissions for COVID-19 diagnostics.

The FDA’s revised policy for COVID-19 tests, issued on 15 November, says new diagnostics should get an OK from...

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