ISSUE: The last decade have seen a dramatic change in the availability of electronic data sources (e.g. registries, claims data, EHR) that capture data during routine patient care. Yet, the health care system and the regulatory setting in particular, do not fully leverage the wealth of such evidence.  Danica Marinac-Dabic will moderate the session and provide an overview of the foundational work in infrastructure and methodologies development undertaken by the Medical Device Epidemiology Network (MDEpiNet), a PPP stood up by the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). OVERVIEW: The FDA/CDRH is spearheading the development of the National Evaluation System for Medical Devices, as part of the US learning health care system. Envisioned as a “network of networks”, the system would use a variety of data sources (“nodes”), to enable critical functions of device evaluation including active surveillance, understanding of product benefit/risks in a real-world clinical setting and the new product development and approval.  However, the Unique Device Identifier (UDI), a critical foundational component of such a system is currently not implemented in most of the existing electronic health records and medical claims. Medical device registries do capture some form of device identification but are not systematically linked to other data sources for longitudinal follow-up and assessment. Although the pockets of US health care ecosystem had made substantial investments in the development of variety of tools, policies and best practices for improving evidence generation and appraisal, the regulatory evaluation of medical devices still does not fully realize the opportunities of incorporating the real world evidence. What are the key gaps in incorporation of RWE to medical device evaluation? What lessons can be learned from current efforts (e.g. MDEpiNet and ongoing FDA practices)? This session will review the obstacles and offer potential solutions.