FDA Takes Authority to Regulate Single Labs’ Medical Tests (2)

Tests used to detect Covid-19, blood infections, or other conditions and diseases will be regulated by the FDA after the agency Monday finalized a rule giving it authority over the diagnostics.

The Food and Drug Administration’s rule (RIN 0910-AI85) gives the agency explicit authority to regulate medical tests that come from a single laboratory, also known as lab-developed tests (LDTs), and label them as medical devices under the Federal Food, Drug, and Cosmetic Act.

The 528-page rule follows the debate on whether the agency should have oversight over the tests. The FDA previously exercised general enforcement discretion for ...