HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic. In withdrawing this policy, HHS said that it “no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”

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