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November 19, 2021

Health Law Weekly

HHS Restores FDA’s Authority over Lab-Developed Tests

  • November 19, 2021

The Department of Health and Human Services (HHS) withdrew November 15 a Trump administration policy that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) absent notice-and-comment rulemaking. HHS said withdrawing the policy will help ensure COVID-19 tests are accurate and reliable.

  • Life Sciences

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