Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests
By EsqSocial Corporation 06/05/25
On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6, 2024, final rule (the LDT Rule). The rule would have subjected laboratory-developed tests (LDTs) to regulation as in vitro diagnostic products (IVDs), which the FDA asserts are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The regulation of LDTs under...
By: McGuireWoods LLP