CDRH Patient Engagement Advisory Committee

2024 Advisory Committee Meeting

On October 30, 2024, the Patient Engagement Advisory Committee (the Committee) will meet virtually to discuss and make recommendations on Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.

The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. The FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.

The Patient Engagement Advisory Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.

For details, see October 30, 2024, Patient Engagement Advisory Committee Meeting Announcement.

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The Patient Engagement Advisory Committee 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:

• 2023: Advancing Health Equity in Medical Devices
• 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:

• 2024
  • Conducted and published a literature review entitled Communicating medical device recalls: A rapid review of the literature to examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products.
  • Infographics in Spanish language for the use of AR/VR devices by patients and healthcare providers
  • Released a discussion paper on health equity in medical devices
• 2023
  • Updated the FDA website to include infographics for the use of AR/VR devices by patients and healthcare providers
• 2022
  • Updated the FDA website to include a list of medical devices that have AR/VR
  • Issued the final guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies”
• 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

• August 28, 2024, Federal Register: Patient Engagement Advisory Committee: Notice of Meeting
• 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
• Requests for Nominations: Voting Members, Patient Engagement Advisory Committee