When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s al­ways a sur­prise when a court has to step in to tell the FDA that it erred in per­form­ing one of its main du­ties: clas­si­fy­ing whether a med­ical prod­uct is drug or a de­vice.

But that’s what the US Court of Ap­peals for the Dis­trict of Co­lum­bia did on Fri­day, mak­ing clear to the world’s top drug reg­u­la­tor that Genus Med­ical Tech­nolo­gies’ con­trast agent bar­i­um sul­fate (al­so known as Vanil­la SilQ) should not be con­sid­ered a drug, as the FDA had said, but a med­ical de­vice.

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