Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

摘要

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will discuss total product lifecycle considerations for Generative Artificial Intelligence (AI)-enabled devices. The meeting will be open to the public. FDA is establishing a docket for public comment on this topic.