An initial focus for the MDIC Early Feasibility Study (EFS) Program included cataloging EFS Performance Metrics following the release of the FDA EFS Guidance in 2013.  Specifically, the MDIC objective is to identify an EFS Performance Metrics Baseline for related Administrative & Clinical Practices.

Publication of the EFS Metrics Baseline is intended to support the following activities:

  • Inform the medical device ecosystem on average expectations related to EFS program participation
  • Inform the MDIC EFS working groups on opportunities to develop EFS Best Practices and Tools
  • Provide a benchmark from which EFS Best Practices and Tools can be evaluated
  • Increase participation in bringing First-in-World medical technologies to US patients through the EFS program.

Project Resources

  • TVT 2017 EFS Presentation: A preview of our EFS Performance Metrics project was presented in June 2017 at the Cardiovascular Research Foundation’s Transcatheter Valve Therapies (TVT) conference.
  • The completed 2017 MDIC EFS Metrics Report: Administrative and Clinical Practices can be found here.