Laboratory, Trade Association Ask Court To Vacate FDA’s Final FDCA Regulation Rule

(September 13, 2024, 8:17 AM EDT) -- SHERMAN, Texas — A national trade association representing leading laboratories and two of its members asked a Texas federal court to grant them summary judgment in their suit against the U.S. Food and Drug Administration and others and to vacate an FDA final rule that laboratory-developed testing services can be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA)....