2020 Advisory Committee Meeting
On October 22, 2020, the Patient Engagement Advisory Committee met to discuss Artificial Intelligence and Machine Learning.
During the meeting, the FDA announced a discussion paper, Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. The discussion paper shares best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities. We encourage you to read the paper and submit comments to the docket by December 21, 2020.
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:
- 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:
- Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance: During the 2017 meeting, the Committee recommended that a FDA develop a framework to clarify how patients could engage as advisors in clinical studies. Based on this recommendation, the FDA issued a draft guidance and is pursuing other efforts to encourage diverse patient engagement in clinical studies.
- Support for the Principle of Openly Sharing Data: The Committee’s recommendations from the 2018 meeting affirmed the importance of sharing data collected by medical devices. In response, FDA sent a letter supporting 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: 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