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# Court Hits FDA Discretion in Drug/Device Decisions
- URL: https://www.fdaweb.com/court-hits-fda-discretion-in-drug-device-decisions/
- Published: 2021-04-19T12:00:00.000Z
- Updated: 2026-09-14T16:55:25.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5149133

The DC Circuit Court of Appeals has affirmed in a [4/16 decision](https://www.cadc.uscourts.gov/internet/opinions.nsf/6320E9D0CAB82210852586B90051B3FC/$file/20-5026-1894856.pdf?ref=fdaweb.com) a district court decision that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug.

At issue in *Genus Medical Technologies v. FDA* was that having a product regulated as a device instead of a drug costs significantly less and subjects the company to less rigorous marketing authorizations, which the appeals court acknowledged in its ruling. More specifically, according to the court, Genus maintained that before and after it started producing its contrast agent Vanilla SilQ, it sought FDA 510(k) clearance to distribute its products as devices. In 2017, FDA issued a Warning Letter notifying the company that its products were “drugs” within the meaning of the Act.

The company disputed the Warning Letter’s findings and both parties were at an impasse after the agency’s Office of Combination Products ruled that the products meet the definition of a drug and also appear to meet the definition of a device. “In short, the agency reasoned that it must regulate contrast agents — which all meet the definition of drugs, but not necessarily devices — uniformly,” the lower court said.

Hyman, Phelps & McNamara, which represented Genus in the case, said the appeals court ruling is a “big win” for industry. “This decision limits FDA’s typically broad discretion and precludes the agency from imposing significant regulatory hurdles and costs based on policy positions rather than the congressionally imposed risk-based regulatory scheme,” it said. “In other words, FDA cannot regulate a device as a drug on a whim.”