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Home » FDA Won’t Require Premarket Approval for COVID-19 Lab-Developed Tests
FDA Won’t Require Premarket Approval for COVID-19 Lab-Developed Tests
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19.
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