Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development

The Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the Digital Medicine Society (DiMe) titled "Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle." The purpose of this co-sponsored public workshop is to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle (TPLC). Patients, industry sponsors, regulators, and researchers will share their perspectives on how using PGHD can help advance remote clinical trial data collection and support clinical outcome assessments. The co-sponsored public workshop participants are slated to discuss how using PGHD in medical device development can promote improvements in patient science, patient engagement, and health equity.