U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Devices and Radiological Health
  5. CDRH Patient Engagement
  6. CDRH Patient Engagement Advisory Committee
  1. CDRH Patient Engagement

CDRH Patient Engagement Advisory Committee

Patient Engagement Advisory Committee Meeting: Artificial Intelligence and Machine Learning, Thursday, October 22, 2020 – Virtual Meeting - #PEAC2020

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.

For details, see October 22, 2020: 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.

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:

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

Related information: Meeting materials for the Patient Engagement Advisory Committee


Federal Register Notices

 

Back to Top