Enhancing Post-Market Evidence Generation for Medical Products

This report is a technical document detailing the Medical Product Evidence Generation Framework project, organized by the Reagan-Udall Foundation for the FDA. It describes a series of roundtable meetings and listening sessions aimed at developing a framework to facilitate post-market medical product research integrated into clinical care. The report outlines actions necessary to address gaps in clinical evidence that inform patient care and support regulatory decision-making regarding medical product claims. An Expert Panel led the project, drafting recommendations for the FDA and other stakeholders on encouraging and supporting evidence generation during routine care delivery. The document includes sections on background, methodology, stakeholder input, and specific recommendations, as well as appendices containing panelist biographies and details of the roundtable discussions. The project received funding from the FDA, emphasizing the collaboration between regulatory bodies and medical research.