Texas Federal Judge Vacates FDA’s Final FDCA Regulation Rule On Lab Test Services

( April 1, 2025, 2:59 PM EDT) -- SHERMAN, Texas — A final rule by the U.S. Food and Drug Administration that laboratory-developed testing services can be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) exceeds the agency’s statutory authority, a Texas federal judge held March 31 and vacated the rule....