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Important Due Dates: The Digital Health Advisory Committee Will Meet to Discuss Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

Below is important information about the FDA’s upcoming Digital Health Advisory Committee Meeting to discuss the Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical 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

Digital Health Advisory Committee (DHAC) Day 1 | 20 NOV 2024
Digital Health Advisory Committee (DHAC) Day 2 | 21 NOV 2024

Meeting Materials

• Executive Summary for the November 20-21, 2024 Digital Health Advisory Committee Meeting
• FDA Discussion Questions for the November 20-21, 2024 Digital Health Advisory Committee Meeting

Important Participation Due Dates

Interested persons may present data, information, or views, orally or in writing, on issues pending before the advisory committee.

• October 25, 2024: Email james.swink@fda.hhs.gov to request to make oral presentations during the public comment sessions.
• November 1, 2024: Submit written materials through the public docket (FDA-2024-3924) to be reviewed by the advisory committee prior to the meeting.
• November 12, 2024: Request special accommodations for the meeting.
• January 21, 2025: Submit written comments to the docket for review and consideration by the FDA.

Questions?

If you have questions about the Digital Health Advisory Committee, email james.swink@fda.hhs.gov.