Medical Device Postmarket Surveillance/Infrastructure Research Summary
Investigator: Art Sedrakyan, MD, Weill Cornell Medicine
The purpose of this FOA is to continue to facilitate development of the National Medical Device Postmarket Surveillance System, epidemiologic methodologies and scientific systems to facilitate a comprehensive understanding of medical device performance and clinical outcomes associated with medical device use.
Specifically, the aims of this FOA are:
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.