Top Food and Drug Cases 2019 and Cases to Watch 2020: Genus Medical Technologies, LLC vs. U.S. Food and Drug Administration

October 8, 2020By: Anne K. Walsh & Sara Koblitz Download PDF

For more than twenty years, the U.S. Food and Drug Administration’s (“FDA’s” or “the Agency’s”) position has been that it could regulate a product as either a drug or a medical device as long as the product meets both statutory definitions. The implications of this approach, however, lead to a significantly more onerous regulatory
standard for products that, based on FDA’s self-granted whim, FDA deems to be a drug rather than a medical device. In Genus Medical Technologies v. FDA, the U.S. District Court for the District of Columbia rejected FDA’s long-held position and limited FDA’s discretion with respect to product classification.

The Court, relying on the plain language of the definitions for “drug” and “device” set forth in the Federal Food, Drug, and Cosmetic Act (“FDCA”), rejected the position that FDA “could classify any diagnostic device as a drug because no limiting principle would trammel its authority.”  The Court mandated FDA to regulate as a device any
product that meets the statutory definition in the FDCA. This case is a good example of a federal court limiting the deference it gives to FDA where the plain meaning of the FDCA places strict limits on FDA’s administrative decisions.

Shared with the permission of FDLI

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