2023 Advisory Committee Meeting

On September 6, 2023, in a virtual meeting, the Patient Engagement Advisory Committee (the Committee) will meet to discuss and make recommendations on Advancing Health Equity in Medical Devices.

FDA CDRH is committed to working toward assuring that all patients have access to high-quality, safe and effective medical devices. This includes ensuring devices are designed to be safe and effective when used by various populations, are evaluated in the diverse populations for which they are intended, and that patients and consumers have the information they need to make decisions about their health, care, and quality of life. In addition, technology, including digital health technology, may help bridge gaps in health equity by extending access and bringing health care to patients at home, at work, and in their communities. The recommendations provided by the committee will address considerations for the FDA and industry on these topics.

The Committee will consider ways to advance access to devices that allow for care outside a hospital or clinical care setting, for example, in the home setting.  The Committee will also discuss considerations for improving reach and comprehension of FDA’s patient and caregiver communications, across diverse demographic groups.  Additionally, the Committee will discuss patient-focused considerations for when a device should be evaluated in diverse populations to support marketing authorization.

For details, see September 6, 2023: Patient Engagement Advisory Committee Meeting Announcement.

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The Patient Engagement Advisory Committee (PEAC) is the first and only advisory committee whose members are all patients, caregivers, and representatives of patient organizations.

The FDA established the Committee to help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues involving the regulation of medical devices and their use by patients.

This Committee brings patients, caregivers, patient organizations, and experts together for a broader discussion of important patient-related issues. Such discussions may help inform device innovation, development, evaluation, and access, and help the FDA meet its public health commitment to protect and promote public health.

For details on the Patient Engagement Advisory Committee’s charter and past meeting materials, see Advisory Committees – Patient Engagement Advisory Committee.

Committee Membership

The Committee is made up of a core of nine voting members plus one non-voting industry representative and one voting consumer representative. For specific meetings that need expertise beyond the core membership, the Committee can reach out to experts that participate on this and other advisory panels for the FDA and the National Institutes of Health.

For details on current committee members, see Roster of the Patient Engagement Advisory Committee.

For information about how to nominate yourself or another candidate to participate in the Committee, see Applying for Membership on FDA Advisory Committees.

Discussion Topics

The Committee may advise CDRH on topics such as:

• Agency guidance and policies
• Design of clinical studies
• Real-world data
• Science of patient input
• Communication of device benefits and risks
• Digital health technology

Executive Summaries from previous Committee meetings include:

• 2022: Augmented Reality and Virtual Reality Medical Devices
• 2021: Medical Device Recalls: Patient-Focused Communications
• 2020: Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices
• 2019: Cybersecurity in Medical Devices
• 2018: Patient-Generated Health Data
• 2017: Patient Engagement in Medical Device Clinical Trials

Actions taken by the FDA in response to feedback from the Committee meetings include:

• 2021
  • Hosted the Virtual Public Meeting - Patient-Generated Health Data (PGHD) Throughout the Total Product Life Cycle of Medical Devices 
  • Published Artificial Intelligence/Machine Learning (AI/ML) action plan that includes a diversity plan to support regulatory science efforts in the identification and elimination of bias in AI/ML algorithms 
  • Posted Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework discussion guide
• 2020
  • Posted a video encouraging underrepresented populations to participate in medical device trials  
  • Announced the development of a video miniseries on cybersecurity that includes videos designed for patients
• 2019
  • Issued the draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations” 
• 2018
  • Supported the principle of sharing data collected by medical devices to help protect and promote public health

Related information: Meeting materials for the Patient Engagement Advisory Committee

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Federal Register Notices

• Federal Register: Patient Engagement Advisory Committee; Notice of Meeting
• Federal Register: Establishment of the Patient Engagement Advisory Committee
• Federal Register: Nominations for Industry Representative for PEAC
• Federal Register: Nominations for Consumer Representative for PEAC
• Federal Register: Nominations for Committee Members for PEAC
• October 4, 2016 - Requests for Nominations: Voting Members, Patient Engagement Advisory Committee