FDA Digital Health Advisory Committee

2025 Advisory Committee Meeting

On November 6, 2025, the Digital Health Advisory Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. The Committee will discuss the benefits, risks to health, and risk mitigations that might be considered for these new digital mental health devices, including premarket evidence and postmarket monitoring considerations. 

The meeting will be held virtually. The FDA intends to make a webcast link available to the public no later than two business days before the meeting. The meeting will be open to the public. Registration is not required to attend the meeting.

To request to make oral presentations during the public comment session of the meeting, email Letise.Williams@fda.hhs.gov by October 9, 2025.

Additional information about the meeting is available on the Digital Health Advisory Committee meeting webpage.

2024 Advisory Committee Meeting

The Digital Health Advisory Committee held its inaugural meeting on November 20-21, 2024. Learn more about this meeting.

What is the Goal of the Digital Health Advisory Committee?

The Digital Health Advisory Committee advises the Commissioner of Food and Drugs on issues, policies, and regulations related to Digital Health Technologies (DHTs). The committee will provide 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

Letise Williams
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Building 66, Room 5407
Silver Spring, MD 20993-0002
Telephone: 301-796-8398
E-mail: Letise.Williams@fda.hhs.gov