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  1. Digital Health Advisory Committee

Charter of the Digital Health Advisory Committee

Authority

The Digital Health Advisory Committee is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 355h, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14; and is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. 1001 et seq).

Purpose

The goal of this committee is to convene experts to provide recommendations based on their interpretation of the evidence, informed by their scientific, clinical, and other relevant expertise. Historically, the Digital Health Advisory Committee has been convened to provide recommendations related to assuring that digital health technologies (DHTs) intended for use as a stand-alone medical product, as part of a medical product, or as a companion, complement, or adjunct to a medical product are safe and effective for human use.

Objectives and Scope of Activities

The Committee advises and informs the Commissioner of Food and Drugs or appropriate designee(s) about the existing and relevant evidence of benefits and risks of DHTs and any related issues such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, etc. The goal of this committee is to convene experts to provide recommendations based on their interpretation of evidence, informed by their scientific, clinical, or other relevant expertise. The recommendations of this Committee will help FDA make informed decisions about the product/s or issues under consideration. Except where legally required to conduct a closed meeting, the committee meetings will be open to the public, consistent with 5 U.S.C. 1009 and in the interest of scientific innovation, education, and transparency. For clarity, the committee provides advice and recommendations, but FDA retains full regulatory decision-making authority on the issues associated with the products or issues under consideration.

Description of Duties

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of DHTs and, as required, any other products for which the FDA has regulatory responsibility. The Committee may consider the quality and relevance of FDA’s research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner of Food and Drugs. Meetings are convened as appropriate consistent with the Agency’s needs and applicable legal and regulatory authorities.

Agency or Federal Officer Receiving the Advisory Committee’s Advice/Recommendations

The Committee provides advice to the Commissioner of Food and Drugs.

Support

Management and support services shall be provided by the Office of the Commissioner, Principal Deputy Commissioner, and/or the relevant Centers, Offices, and Programs.

Estimated Annual Operating Costs and Staff Years

The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $85,578. The estimated person years of staff support required is 0.50, at an estimated annual cost of $105,723.

Designated Federal Officer

The Commissioner will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all activities are within applicable statutory, regulatory, and HHS General Administration Manual directives, and any other relevant policies and procedures. The DFO will approve and prepare all meeting agendas, call all the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest, and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees. The DFO will also ensure committee members and subcommittee members, as applicable, receive appropriate training for efficient operation and compliance with all relevant member policies and procedures and applicable law. The DFO maintains information on committee activities and provides such information to the public as applicable, including as required by 5 U.S.C. § 1009(b).

Estimated Number and Frequency of Meetings

FDA will convene the Committee as needed. The frequency of meetings will vary from year to year, depending on the specific issues upon which Committee’s advice and recommendations are sought. FDA is not required to convene the committee each calendar year.

Public Transparency

Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all such meetings shall be given to the public.

Duration

The duration of the advisory committee is continuing, subject to the Termination section below.

Termination

Unless renewed by appropriate action, the Digital Health Advisory Committee will terminate two years from the date the charter is filed.

Membership and Designation

The Committee shall consist of at least two voting members including the Chair. Subject to legal and regulatory requirements, members and the Chair are selected by and serve at the discretion of the Commissioner or designee. Each member, including the Chair, will be selected from among authorities knowledgeable in the fields of digital health, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, software development, user experience, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, cybersecurity, and implementation in clinical practice of and patient experience with digital health, as well as other relevant areas.

Members may be invited to serve for terms of up to four years, or for less time in the discretion of the Commissioner or designee. Non-Federal members of this committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or Ex-Officios.

Members may be invited to vote on recommendations, with the exception of consumer or industry representatives. The Commissioner of Food and Drugs or designee may, identify consumer and/or industry representatives to join the Committee (or serve as alternate representatives) as non-voting representative member(s), via a process consistent with legal and regulatory requirements. Individuals currently employed at FDA-regulated companies, such as pharmaceutical and medical device manufacturers, shall not be selected to serve as members of the Committee unless this Committee is expected to address issues for which inclusion of an industry representative is required by statute. If this Committee includes an industry representative, the Commissioner or desingee will determine whether to invite them to participate in meetings on a case-by-case basis, according to applicable legal and regulatory requirements.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members); (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking; or (3) when considered appropriate in the discretion of the Commissioner or designee.

A quorum for the Committee is a majority of the current voting members present at the time, provided that FDA may, in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members because of the size of the Committee and the variety in the types of issues that it will consider, or other reason determined appropriate in accordance with legal and regulatory requirements. 21 CFR §14.22(d).

Members appointed to an advisory committee serve for the duration of the committee, or until their terms expire, they resign, or they are removed from membership by the Commissioner or designee. Committee members’ terms may be ended prior to their date of expiration, for reasons determined to be good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interefers with the ability to render objective advice, failure to abide by established procedures, or violation of other applicable rules and regulations.

Subcommittee

Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.

If requested, subcommittees may make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee. Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency or any other Federal officer.

Conflicts of Interest

All members of the Committee, including any consumer or industry representatives, will be subject to appropriate conflicts of interest standards and obligations, as applicable for Special Government Employees (SGEs), Regular Government Employees (RGEs), and non-Government Employees (NGE).

Before each meeting on a particular matter, all Committee members are screened for conflicts of interests according to legal and regulatory requirements in place based on their role as SGE, RGE, or NGE, and evaluated according to laws and regulations governing federal advisory committees and the ethics of government employees. SGEs and RGEs will be screened consistent with the requirements of 18 U.S.C. 208, 21 U.S.C. § 379d-1, 5 CFR § 2640, and 5 CFR § 2635.502. NGE representative members will be screened according to their role and relevant statutory provisions, including any such screening needed to confirm compliance with the requirement that industry representatives not be “directly affected” by the matter at issue. 21 CFR 14.86(c)(4). As appropriate, this screening may include review of detailed financial disclosures, including investments, employment, consulting engagements, contracts, grants and cooperative research and development agreements, as well as patents, royalties, trademarks, involvement in matters as an expert witness, speaking and writing engagements, and other interests related to the product or issue for which the meeting is convened.

In accordance with legal and regulatory requirements, members of the Committee shall be recused for potential conflicts unless FDA issues an appearance authorization under relevant legal and regulatory authorities, or unless the conflict is waived by the Commissioner or, where appropriate, designee.

Recordkeeping

Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws and Departmental policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records or other approved Agency records disposition schedule. These records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.

Filing Date

October 24, 2025

Approved

Date: October 24, 2025

/S/

Dr. Sara Brenner, M.D., M.P.H.
Principal Deputy Commissioner

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