Our Projects

 

Medical Device Postmarket Surveillance/Infrastructure Research Summary

Investigator: Art Sedrakyan, MD, Weill Cornell Medicine

Purpose:

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.