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FDA Proposes Regulating LDTs as Medical Devices, Again

October 5, 2023

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and offered by a single clinical laboratory and they make up the substantial majority of clinical laboratory testing today……
By: Bass, Berry & Sims PLC

FDA Proposes Regulating LDTs as Medical Devices, Again

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