Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01)

1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes.