FDA Issues Final Rule Designating In Vitro Diagnostic Products As Medical Devices

(May 7, 2024, 1:53 PM EDT) -- SILVER SPRING, Md. — The U.S. Food and Drug Administration on May 6 issued a final rule amending a regulation “to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act . . . including when the manufacturer of the IVD is a laboratory.”...

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