Genus Scores Win in FDA Battle Over Classification of Product

The Food and Drug Administration acted unlawfully when it classified Genus Medical Technologies LLC’s contrast agent as a drug rather than a device without first considering how it works, a federal appeals court said Friday.

A product’s classification makes a big difference because it’s much costlier to develop and market a drug than a device, according to the U.S. Court of Appeals for the District of Columbia Circuit.

Genus, for example, said it would cost about $60,000 to obtain device clearance for its product, while the company would have to spend about $500,000 to obtain the FDA’s approval to market ...