Per the notice below, the United States Food and Drug Administration (FDA) is holding a meeting of its Digital Health Advisory Committee that will be Webcast for free.
The Digital Health Advisory Committee Will Meet to Discuss Total Product Lifecycle Considerations for Generative AI-enabled Medical Devices  The U.S. Food and Drug Administration (FDA) is announcing that the inaugural Digital Health Advisory Committee meeting will occur November 20-21, 2024. Registration is not required to attend. During this meeting, the advisory committee will discuss total product lifecycle considerations for generative AI-enabled medical devices. The committee will also discuss how the use of generative AI-may impact safety and effectiveness of medical devices enabled with this technology. The Committee will discuss premarket performance evaluation, risk management, and postmarket performance monitoring for generative AI-enabled devices. |
- Meeting Dates:
- November 20, 2024, 9 a.m. – 6 p.m. ET
- November 21, 2024, 9 a.m. – 6 p.m. ET
- Location:
- In person
- Holiday Inn Gaithersburg
Two Montgomery Village Ave., Gaithersburg, MD 20879
- Webcast
Important Deadlines- October 25, 2024: Request to make oral presentations during the public comment sessions.
- November 1, 2024: Submit written materials through the public docket (FDA-2024-N-3924) at www.regulations.gov to be reviewed by the committee prior to the meeting.
- November 12, 2024: Request special accommodations for the meeting/workshop.
- January 22, 2025: Submit written comments to the docket.
Questions?If you have questions about the Digital Health Advisory Committee, e-mail: james.swink@fda.hhs.gov. |
