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On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
On March 31, 2025, the U.S. District Court for the Southern District of Texas vacated the FDA’s Final Rule on laboratory-developed tests (LDTs), holding that the agency lacks authority to regulate LDTs as medical devices...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more