Lexology August 11, 2021
In a notice published in the Federal Register on August 9, 2021, the U.S. Food and Drug Administration (FDA) announced it will implement a recent court decision and will begin to reclassify as devices certain diagnostic imaging agents that had been approved as drugs.
In April, the U.S. Court of Appeals for the District of Columbia Circuit ruled in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 that the FDA did not have regulatory authority to classify some diagnostic imaging contrast agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act. In the Genus litigation, both the District Court and the Court of Appeals disagreed with FDA’s...
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