LeadLaura Housman

In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) this April issued a long-anticipated rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs’ regulatory framework with that of medical devices and details the agency’s rationale for removing enforcement discretion from most LDTs. The rule expands the FDA’s authority over a broader set of products to mitigate public concerns over misleading or false test results.