FDA loses ‘drug or device’ argument again

Drug or device? Genus Medical Technologies says it’s a device. (Image from Genus Medical Technologies)

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug.

The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.

Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does.

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