Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a cru­cial court case in which its broad dis­cre­tion of reg­u­lat­ing med­ical prod­ucts that might sat­is­fy the le­gal de­f­i­n­i­tions of ei­ther “drug” and/or “med­ical de­vice” was sharply cur­tailed.

In ad­di­tion to the ap­peals court rul­ing that Genus Med­ical Tech­nolo­gies’ con­trast agent bar­i­um sul­fate (aka Vanil­la SilQ) should not be con­sid­ered a drug, as the FDA had ini­tial­ly ruled, but as a med­ical de­vice, the agency al­so was forced to spell out which drugs would tran­si­tion to de­vices as a re­sult of the rul­ing.

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