2021 Advisory Committee Meeting
On October 6, 2021, the Patient Engagement Advisory Committee will meet to discuss and make recommendations on Medical Device Recalls.
The purpose of this virtual public meeting is to address factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The Committee will consider concerns patients have about changes to their device in response to a recall and discuss ways patient perspectives could be incorporated in the FDA’s and industry’s benefit-risk decision-making of recalled medical devices. The Committee will also consider the patient and healthcare provider decision-making process related to recalled devices, including implanted devices.
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:
- 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: 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