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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.
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Meeting Dates:
- November 20, 2024, 9 a.m. – 6 p.m. ET
- November 21, 2024, 9 a.m. – 6 p.m. ET
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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 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, email james.swink@fda.hhs.gov.
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