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Federal Food Drug and Cosmetic Act (FFDCA) Laboratory Developed Tests Vacated

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

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

Venable LLP

Federal District Court Vacates FDA’s LDT Final Rule

Venable LLP on

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

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