FDA Makes Clear Its Intention to Regulate Diagnostic Tests

The FDA plans to give itself explicit powers over medical tests that come from a single laboratory in a move that would settle a longstanding debate about how far its device regulations can go.

The announcement of the Food and Drug Administration’s intent to issue a proposed rule on laboratory developed tests (LDTs) appeared Tuesday in the unified agenda, a biannual publication of the US government’s expected regulatory actions. The tests are used to detect diseases, conditions, and infections.

The LDT proposal (RIN: 0910-AI85) makes good on the agency’s promise to move forward with regulations after Congress failed ...