PURPOSE: This workshop will focus on recommendations from a U.S. National Medical Device Registry Taskforce appointed to propose an approach to strengthen the medical device post-market surveillance system using current resources and to develop an integrated system to perform a range of functions. Participants will become familiar with alternative strategies for capitalizing on diverse, heterogeneous existing data sources, methodological challenges in combining information across the diverse data sources, and the opportunities and risks of such data for device evaluation. DESCRIPTION: Participants will obtain an overview of the current challenges associated with evaluating medical devices within a national system with a focus on the use of strategically Coordinated Registry Networks (CRNs). Dr. Marinac-Dabic will provide a description of the evolution of registry science in the device regulatory setting from “one off” studies to strategic applications. Dr. Sedrakyan will next review the key infrastructure requirements for medical device evaluation as well as priority medical devices. Dr. Normand will introduce CRNs, describe the statistical challenges emerging from the use of CRN data, methodological opportunities that exploit data heterogeneity for label extensions and for new medical devices. Workshop participants should have some quantitative background and some basic familiarity with medical device evaluations.