> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments Extended on FDA ’Genus’ Notice
- URL: https://www.fdaweb.com/comments-extended-on-fda-genus-notice/
- Published: 2021-10-01T12:00:00.000Z
- Updated: 2026-09-14T17:17:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150269

*Federal Register* notice: FDA has extended the comment period for the notice entitled *Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments* that appeared in the 8/9 *Federal Register*. A 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. Comments now can be submitted by 11/30\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-01/pdf/2021-21403.pdf?ref=fdaweb.com).