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
You must be logged in to access this content.