On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for.
Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by the U.S. Food and Drug Administration, the agency announced Monday. Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by the U.S. Food and Drug Administration, the agency announced Monday.
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug.