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  1. Guidance & Regulatory Information

Genus v. FDA D.C. Circuit Court Decision and transition from drugs to devices

FDA announced some approved products are expected to transition from drug status to device status as a result of the U.S. Court of Appeals for the District of Columbia Circuit decision in Genus Medical Technologies v. FDA.

FDA intends to regulate products that meet the definitions of both devices and drugs as devices, including products the agency may have previously classified differently except where the statute indicates Congress intended a different classification.

FDA intends to publish a Federal Register notice with a list of approved drugs we tentatively determine should transition to device status as a result of this court decision. Stakeholders will have an opportunity to comment on those individual product determinations before the agency makes its final decisions on the classifications.

FDA does not expect the transition from drug status to device status will be completed before October 1, 2021.

Sponsors of new drug applications or abbreviated new drug applications should pay the FY 2022 user fees by the due date to avoid being placed on the arrears list and incurring other penalties. Sponsors may request refunds for those fees, and FDA anticipates refunding user fees for those products that transition from drug status to device status. See the announcement for more information.

Stakeholders may submit comments concerning the transition process from drug to device status and the timeline for this transition by October 8, 2021.

No action is needed on marketed products until FDA notifies product sponsors. The agency will update this page as more information becomes available. Contact drug_device_transition_inquiry@fda.hhs.gov with questions. 

Please contact combination@fda.gov with questions about other product classification or assignment issues unrelated to this notice.

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