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FDA Digital Health Advisory Committee

Digital Health Advisory Committee Meeting. TPLC considerations for Generative AI-enabled Devices. November 20-21, 2024

2024 Advisory Committee Meeting

On November 20-21, 2024, the Digital Health 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 also discuss premarket performance evaluation, risk management, and postmarket performance monitoring for generative AI-enabled devices.

Additional information is available on the Digital Health Advisory Committee page.

What Is the Goal of the Digital Health Advisory Committee?

The Digital Health Advisory Committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with use of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA's regulation.

Committee Membership

The Committee shall consist of a core of 9 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of digital health. The number of temporary members selected for a particular meeting will depend on the meeting topic.

For details on current committee members, see Roster of the Digital Health Advisory Committee.

Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws and policies of the U.S. Department of Health and Human Services.

Contact Information

James Swink
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66
Silver Spring, MD 20993-0002
telephone:301-796-6313
fax: 301-847-8510
e-mail: james.swink@fda.hhs.gov

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