Posted by Michael Wonder on 09 Dec 2019
Court rules against FDA’s finding that a device was a drug
9 December 2019 - Whether the US FDA classifies a product as a drug or a device can have huge implications for the sponsor, partly because of how the agency reviews the different products and partly because of the increased cost of bringing a drug to market.
For Missouri-based Genus Medical Technologies’ contrast agent Vanilla SilQ, which people drink before undergoing an X-ray, the US District Court for the District of Columbia recently ruled that FDA made the incorrect decision and that the agent is not a drug.
Marketed since 2015 as a device, as the contrast agent is “neither absorbed nor metabolised” by the body, FDA in May 2017 sent the company a warning letter claiming that its product is actually a drug. In backing its claim, FDA said that contrast agents — which all meet the definition of drugs, but not necessarily devices — must be regulated uniformly.
