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FDA vacates final rule regulating lab-developed tests as medical devices
The Food and Drug Administration released a
FDA Rescinds the Laboratory Developed Test Final Regulation
The AHA appreciates that the FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care.
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.