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Advisory
Member

FDA Issues Final Rule to Regulate Laboratory Developed Tests as Medical Devices

Advisory
The Food and Drug Administration (FDA) on April 29 issued a final rule that will phase out, over four years, its general enforcement discretion approach for in vitro diagnostic tests (IVDs), which include laboratory developed tests (LDTs).
Testimony

AHA Statement on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule."

Testimony
AHA statement before the House Committee on Energy and Commerce Subcommittee on Health on the impact of the Food and Drug Administration’s (FDA) proposed regulation of diagnostic tests.