Per the notice below, the United States Food and Drug Administration (FDA) is seeking public comment on generative artificial intelligence (AI) used to enable medical/dental devices.

Submit Comments: Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

The FDA’s Digital Health Advisory Committee met in November 2024 to discuss the Total Product Lifecycle Considerations for Generative Artificial Intelligence (AI)-Enabled Medical Devices.  The FDA encourages you to submit comments on this topic to docket FDA-2024-3924 on or before January 21, 2025.  Please note that late, untimely filed comments will not be considered.

Submit Comments

Meeting Materials

Meeting materials from the November 2024 Digital Health Advisory Committee Meeting, including the agenda, discussion questions, roster, executive summary, webcast recording, transcript, and presentation slides are available on the page: November 20-21, 2024: Digital Health Advisory Committee Meeting Announcement.

Questions?

If you have questions about the Digital Health Advisory Committee, e-mail: james.swink@fda.hhs.gov.