US FDA's Proposed Rule: Regulating Laboratory Developed Tests as Medical Devices

On September 29, 2023, the FDA proposed a rule to classify laboratory developed tests (LDTs) as in vitro diagnostic products (IVDs) regulated as medical devices. This move would end the historical enforcement discretion policy for most LDTs. The FDA believes that modern LDTs are equivalent to traditional IVDs and should be subject to the same regulations due to concerns about patient safety and accuracy. The proposed rule outlines a phased approach to implement these changes over four years. Comments on the proposal are open until December 4, 2023, and it is likely to spark debates, potential litigation, and congressional discussions about the FDA's authority over LDTs.

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