9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.

In April, FDA lost a court battle (Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify some barium sulphate contrast imaging agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act. 

The classification of barium sulphate contrast agents, FDA explained, was “intended to be consistent with a previous court decision” and done so the agency could regulate all contrast imaging agents under an authority in the Center for Drug Evaluation and Research.

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