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.