In September 2015, the FDA announced its first Patient Engagement Advisory Committee. The FDA is establishing 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 will bring 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.