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# FDA Implementing Fallout from Drug/Device Case
- URL: https://www.fdaweb.com/fda-implementing-fallout-from-drug-device-case/
- Published: 2021-08-06T12:00:00.000Z
- Updated: 2026-09-14T17:09:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149881

*Federal Register* notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in *Genus Med. Techs., LLC v. FDA.* The 4/16 decision [affirmed](https://www.cadc.uscourts.gov/internet/opinions.nsf/6320E9D0CAB82210852586B90051B3FC/%24file/20-5026-1894856.pdf?ref=fdaweb.com) a district court ruling that FDA is not afforded discretion when a combination product meets the definition of both a device and a drug ([see earlier story](https://www.fdaweb.com/court-hits-fda-discretion-in-drug-device-decisions/)). The notice provides information for stakeholders and solicits public comment to inform the agency’s deliberations about products potentially impacted by the *Genus* decision and the way in which impacted products should be transitioned from drug to device status. For example, implementation will require FDA to transition some approved products from drug status to device status. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-16944.pdf?ref=fdaweb.com).