Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021) is expected to require some approved products to transition from drug status to device status. This notice provides information for stakeholders and solicits public comment to inform the Agency's deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status.
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