Skip to Main Content

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.

ARTICLE TAGS
  • Life Sciences

You must be logged in to access this content.