FDA Outlines New Stance On Patient-Specific Devices

Law360, New York (January 14, 2014, 6:17 PM EST) -- The U.S. Food and Drug Administration on Tuesday issued draft guidance to the medical device industry on how medical devices personalized for patients can qualify for the custom device exemption to the Food, Drug and Cosmetic Act, defining caps and reporting requirements.

The new guidance contains recommendations from the FDA on how the medical device industry should comply with a 2012 provision amending an existing custom-device exemption in the FDCA that introduced new concepts and procedures for custom devices. The FDA’s guidance, which contains recommendations that...
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