The FDA has formed a patient engagement advisory committee that will provide advice on complex issues relating to medical devices, the regulation of devices, and their use by patients.
The committee will consist of a core of nine voting members, including the chair. Members and the chair are selected by the commissioner or designee from experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States.
Topics the committee may consider include: 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 and device-related quality of life or health status issues, and other patient-related topics.
The commissioner will also have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with industry interests. The number of temporary non-voting members selected for a particular meeting will depend on the meeting topic.