Patient Science Informing Regulatory Decision-Making Across the Total Product Lifecycle (Conference Presentation)

A shift toward increased patient-centeredness is taking place in healthcare, from clinical care to medical product innovation, evaluation, and reimbursement decision-making. The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has engaged the scientific and patient communities in developing rigorous scientific methods to integrate patient input into regulatory decision-making. This patient input comes in several forms, including patient-reported outcomes (PROs) and patient preference information (PPI). These studies have helped identify unmet needs, develop novel endpoints, improve clinical investigation design, and inform the benefit-risk assessment.