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HHS Revokes Trump Policy That Limited Reviews of Some COVID Tests

POLITICO Pro

16 Nov 2021

Stacy Cline Amin spoke to POLITICO Pro about the Department of Health and Human Services (HHS) withdrawing a Trump-era legal determination that the Food and Drug Administration (FDA) lacks the authority to require premarket reviews of laboratory developed tests for COVID-19 and other conditions.

According to Stacy, the FDA is prepared to defend its legal position in the event of litigation.

“HHS tried to make law through a web posting, you can’t do that,” Stacy said. “The legal memo that was leaked was inaccurate, incoherent, and inconsistent. I think FDA believes its legal footing is strong.”

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