Court decision on LDTs
On March 31, 2025, the US District Court (Eastern District of Texas, Sherman Division) ruled that the FDA’s Final Rule on Laboratory Developed Tests (LDTs) published in 2024, which phases out enforcement discretion and phases in standard medical device requirements, be vacated and set aside. This court determined that Congress has vested authority of test services to the Centers for Medicare and Medicaid Services (CMS) while medical devices are under the authority of the FDA. They ruled these to be services, rather than devices, and so they fall under the domain of the CMS. They further remanded the matter to the Secretary of Health and Human Services (HHS) for further consideration.
District Court Ruling on FDA Final Rule Regarding Laboratory Developed Tests (LDTs) | Emergo by UL
District Court Ruling on FDA Final Rule Regarding Laboratory Developed Tests (LDTs)
Medical device manufacturers operating in the United States (U.S.) need to be aware of new rules for obtaining market access for laboratory-developed tests (LDTs).
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