FDA Policy/General

Comments Extended on FDA ’Genus’ Notice

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 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). 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.

Comments Extended on FDA ’Genus’ Notice

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