FDA Moves to Cement Diagnostic Test Oversight With Proposed Rule (1)

The FDA would have clear authority to regulate medical tests that come from a single laboratory under a proposal released by the agency Friday.

The proposed rule (RIN: 0910-AI85) marks a pivotal step in the Food and Drug Administration’s mission to settle a longstanding debate over how much oversight the agency has on laboratory developed tests (LDTs) used to detect diseases, conditions, and infections.

The FDA’s proposal would explicitly label LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, and would allow the agency to regulate these products the same way it has historically regulated commercial ...