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US FDA Stuck With Less Flexibility On Drug Vs. Device Designations After Appeals Court Decision

 
• By Elizabeth Orr

Products that seem to meet both drug and device standards will probably now be designated devices after an appeals court concludes that US FDA has less discretion than it has historically exercised.

A contrast agent used during radiology scans is legally a device and not a drug, the DC Circuit Court of Appeals determined on 16 April in a rebuke to the US Food and Drug Administration.

The ruling marked a victory for Genus Medical Technologies, who sued the FDA in 2019 after the agency determined that its barium sulfate products, which are sold under the brand name Vanilla SilQ, should be regulated as drugs

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