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FDA issues final rule applying medical device rules to laboratory developed tests
The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion approach for most laboratory developed tests over four years, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro diagnostic products.
FDA Issues Final Rule to Regulate Laboratory Developed Tests as Medical Devices
The Food and Drug Administration (FDA) on April 29 issued a final rule that will phase out, over four years, its general enforcement discretion approach for in vitro diagnostic tests (IVDs), which include laboratory developed tests (LDTs).