Court de­ci­sion push­es FDA to make his­tor­i­cal shift and reg­u­late bor­der­line drug/de­vice prod­ucts as de­vices

In a ma­jor shift, and a big win for the phar­ma­ceu­ti­cal in­dus­try, the FDA said Fri­day that mov­ing for­ward it in­tends to reg­u­late prod­ucts that meet both the de­vice and drug de­f­i­n­i­tions as de­vices.

The an­nounce­ment is the re­sult of a loss in court for the agency in April, when the US Court of Ap­peals for the Dis­trict of Co­lum­bia said that Genus Med­ical Tech­nolo­gies’ con­trast agent bar­i­um sul­fate, known as Vanil­la SilQ, should not be reg­u­lat­ed as a drug, as the FDA had said, but as a med­ical de­vice.

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