Contrast Dye Is a Medical Device, Not a Drug, Court Says

The Food and Drug Administration must reconsider its decision to classify a contrast dye as a drug instead of as a medical device, because that decision was contrary to the plain language of the Food, Drug, and Cosmetic Act, a federal court in Washington, D.C., said Dec. 6.

The FDCA defines both drugs and devices as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” the U.S. District Court for the District of Columbia said.

But the law’s definition of devices excludes items that don’t achieve their “primary intended purposes ...