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Regulatory Focus™ > News Articles > FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

Posted 18 September 2015 | By Zachary Brennan 

FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices.

The committee, which will be made up of nine voting members, one non-voting industry representative and one non-voting consumer representative, will bring together patients, patient advocacy groups, and experts for a broader discussion on device innovation, development, evaluation and access.

Candidates for PEAC

As far as who will be included in the committee, FDA encourages the public to nominate a diverse group of candidates with knowledge in areas such as:

  • primary care patient experience
  • healthcare needs of patient groups in the US
  • the work of patient and health professional organizations
  • clinical research
  • methodologies for eliciting patient preferences
  • patient reported outcomes methodology
  • strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.

FDA is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization.

CDRH Acting Associate Center Director for Science and Strategic Partnerships Kathryn O’Callaghan told journalists on Friday at a symposium that the first meeting will be next year and the committee will be a resource focused on what’s happening in the patient community and their perspectives.

As far as what issues the committee will focus on initially, FDA is asking for public comment on the decision. PEAC may advise CDRH on guidance, clinical trial design, patient preferences, device labeling, unmet clinical needs and benefit-risk determinations.

“We are entering an era of ‘patient-centered’ medicine in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care,” Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., wrote in a blog post.

Patient representatives currently participate in FDA advisory committee meetings, though the agency has never created a committee entirely focused on patients. And for meetings that need further expertise, the PEAC can reach out to experts who participate on other advisory panels for FDA and the National Institutes of Health.

Patient Engagement Advisory Committee (PEAC)


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