Laboratory, Trade Association Challenge FDA’s Final FDCA Regulation Rule

(June 6, 2024, 8:27 AM EDT) -- SHERMAN, Texas — A national trade association representing leading laboratories and two of its members sued the U.S. Food and Drug Administration and others in a Texas federal court challenging a recently published final rule that laboratory-developed tests will be regulated as medical devices under the federal Food, Drug and Cosmetic Act (FDCA)....

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