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  1. CDRH Patient Science and Engagement Program

CDRH Patient Engagement Advisory Committee

 

PEAC 2021 - Medical Device Recalls October 6, 2021

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.

For details, see October 6, 2021: 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

 

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