PURPOSE: Real-world evidence (RWE) is gaining an increasingly important role in the evaluation of medical devices. However, epidemiological, comparative effectiveness, and other varieties of medical device RWE present numerous unique challenges which are often not applicable to such studies on pharmaceuticals. The purpose of this workshop will be to provide participants with a fundamental understanding of these challenges and ways in which they can be addressed in applied research settings. DESCRIPTION: The first presenter will review the use cases, strengths, and limitations of available data sources for medical device research – including those commonly used for pharmaceutical research. Such data sources include hospital data, electronic medical records, administrative claims data, registries, the Manufacturer and User Facility Device Experience Database, and publicly-available survey data, among other sources. The second presenter will discuss specific approaches and challenges to medical device identification in databases with examples, followed by an overview of the Unique Device Identifier, its status relative to dissemination in real-world data sources, and its potential to shape the future of medical devices research. The third presenter will discuss the idiosyncrasies of how bias may arise in medical device research – including hospital and provider-level confounding, healthy-user bias, new medical device learning curves, among other issues – along with statistical and study design approaches that may be implemented to address such matters. The final presenter will discuss imminent and emerging sources of nontraditional medical device data, including information collected from ‘smart’ implantable devices, wearables, mobile health platforms, and other ‘internet of things’ platforms. Throughout the workshop, presenters will use a web-based instant audience response system to interactively poll participants on their experiences, opinions, and insights. The workshop will provide practical, specific, and actionable information for those who wish to advance their understanding of the fundamentals and emerging trends of medical device RWE.