About FDA

CDRH Patient Engagement Advisory Committee

The FDA is requesting feedback from patients, patient advocates, medical device industry, clinical researchers, and the public on patient engagement in medical device clinical trials. The feedback the FDA receives on this topic will be used to help develop a draft guidance on this topic. The docket for comments will be open through January 8, 2019.

Silouettes of people of all ages with thought bubbles above their heads.In September 2015, the FDA announced its first Patient Engagement Advisory Committee. 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, patient advocacy groups, 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 improve patients’ health and quality of life.

For details on the Patient Engagement Advisory Committee, see:

Committee Membership and Qualifications

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 other advisory panels for the FDA and the National Institutes of Health.

The FDA encourages the public to nominate candidates that represent the full spectrum of demographics, including women and men, members of all racial and ethnic groups, of disease severity and individuals with and without disabilities to serve on the committee. CDRH is seeking individuals who are knowledgeable in areas such as:

  • Primary care patient experience
  • Healthcare needs of patient groups in the United States
  • 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.

How to Nominate a Candidate

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 the following topics:

  • Agency guidance and policies
  • Clinical trial or registry design
  • Patient preference study design
  • Benefit-risk determinations
  • Device labeling
  • Unmet clinical needs
  • Available alternatives
  • Patient reported outcomes
  • Device-related quality of life or health status issues
  • Other patient-related topics

Federal Register Notices


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