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# Genus Medical Wins Drug/Device FDA Controversy in Court
- URL: https://www.fdaweb.com/genus-medical-wins-drug-device-fda-controversy-in-court/
- Published: 2019-12-09T12:00:00.000Z
- Updated: 2026-09-14T15:55:54.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145681

Genus Medical Technologies has won a [court decision](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2019cv0544-19&ref=fdaweb.com) in Washington, DC federal court to have its contrast agent Vanilla SilQ products regulated as a device as opposed to a drug. Having a product regulated as a device instead of a drug costs significantly less and subjects the company to less rigorous marketing authorizations, the court acknowledged in granting the company’s motion for summary judgment.

In finding for the company, judge **James Boasberg,** an Obama appointee, dismissed FDA’s position that while the contrast agent appeared to qualify as a device under the FDCA, such products were also drugs and could be regulated accordingly. Requiring the company to follow the drug regulatory path to market instead of the device path was “inconsistent with the Administrative Procedure Act,” he wrote.  

According to the opinion, Genus maintained that before and after it started producing 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 Food, Drug & Cosmetic Act (FDCA).

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 opinion summarized.

Boasberg found: “If a product that meets both definitions is nonetheless treated as a drug, then the device-drug distinction would be rendered meaningless. Put otherwise, the FDA could classify any diagnostic device as a drug because no limiting principle would trammel its authority. That would turn the statutory scheme on its head.” He further noted that Congress could have afforded the agency discretion to determine which of these pathways a product must take, as it did in other certain product regulatory matters.

Citing a previous court ruling, Boasberg's decision said that “(b)ecause ‘courts must presume that a legislature says in a statute what it means and means in a statute what it says there,’ the court holds that a product that meets the device definition must be regulated as such.” The matter was remanded to the agency for further administrative proceedings consistent with the court’s opinion.

“This is a big win for industry in limiting FDA’s discretion,” a Hyman, Phelps & McNamara [blog post](http://www.fdalawblog.net/2019/12/court-decides-fda-cant-regulate-device-as-drug/?ref=fdaweb.com) said. The law firm, which represented Genus Medical, said that the decision “supports the proposition that, despite some level of deference by federal courts to agencies, the plain meaning of the FDCA places strict limits on FDA’s administrative decisions, and courts will reject FDA’s administrative decisions when they run counter to clear statutory meaning (likewise, a decision from the Fourth Circuit Court of Appeals [almost exactly five years ago](http://www.fdalawblog.net/2014/12/fourth-circuit-rolls-back-district-court-decision-on-pre-mma-180-day-exclusivity-for-generic-celebre/?ref=fdaweb.com) held FDA had failed to properly apply clear statutory provisions (a blogpost on that decision is linked [here](http://www.fdalawblog.net/2014/12/fourth-circuit-rolls-back-district-court-decision-on-pre-mma-180-day-exclusivity-for-generic-celebre/?ref=fdaweb.com)).”