CDRH Patient Engagement Advisory Committee
2022 Advisory Committee Meeting
On July 12-13, 2022, the Patient Engagement Advisory Committee will meet to discuss and make recommendations on Augmented Reality (AR) and Virtual Reality (VR) Medical Devices.
During this virtual meeting, the Patient Engagement Advisory Committee (the Committee) will discuss and make recommendation on factors to consider when evaluating the benefits, risks, and uncertainty for AR/VR devices. The committee will also discuss specific challenges related to vulnerable populations (for example, pediatric or cognitively impaired) who may use this technology. Additionally, the committee will discuss ways patient perspectives could be incorporated in FDA and industry benefit-risk decision making, as well as the healthcare provider decision-making process related to using or prescribing the technology.
For details, see July 12-13, 2022: Patient Engagement Advisory Committee Meeting Announcement.
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.
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.
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:
- 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:
- 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
- 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
- Issued the draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations”
- 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
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