On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues related to digital health technologies (DHT), including complex scientific and technical issues regarding DHTs in clinical trials, post-market studies, personalized medicine, and cybersecurity. Topics also may include artificial intelligence, machine learning, wearables, virtual reality, digital therapeutics, software, and remote patient monitoring, among others.

The DHA Committee will be composed of nine core voting members, including a chairperson and a consumer interest-oriented technically qualified individual, and an unspecified number of temporary non-voting members. Selected industry representatives will participate as non-voting members. More information regarding the DHA Committee is available in the Federal Register notice. The FDA is soliciting public feedback on potential topics for the DHA Committee, and comments on the notice are due December 11, 2023.

Nominations and applications for the DHA Committee’s non-voting, voting, and consumer-interest members must be submitted on or before November 13, December 11, and November 27, 2023, respectively, through the FDA’s nomination portal or by mailing the FDA’s Advisory Committee Oversight and Management Staff. Interested industry organizations may also participate in the selection process for the DHA Committee’s non-voting members by submitting a statement of interest to the FDA by November 13, 2023. More information on the DHA Committee selection process is available in the Federal Register notices for non-voting, voting, and the voting consumer representative members.

Over the past year, the FDA has issued numerous guidance documents applicable to digital health technologies, including the guidance documents listed below. We expect the DHA Committee to have a significant impact on these and future digital health technology-related FDA guidance.

1. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
2. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
3. Regulatory Considerations for Prescription Drug Use-Related Software
4. Off-The-Shelf Software Use in Medical Devices
5. Content of Premarket Submissions for Device Software Functions
6. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions