EFS Blueprint and EFS/FIH Perspectives Report

In 2015, the MDIC formed a working group which commissioned an Early Feasibility (EFS)/First-in-Human Industry (FIH) Industry Perspectives survey of key medical device industry stakeholders. This EFS/FIH Perspectives survey was the first milestone in an ongoing effort to understand the attitudes and beliefs within the medical device ecosystem towards EFS programs in the U.S., and to ultimately facilitate an increase in the number of EFS projects initiated in the U.S. The full EFS/FIH Industry Perspectives Report (2015) is available here.

The results from that 2015 EFS/FIH Industry Perspectives survey additionally informed development of MDIC’s “Blueprint for Early Feasibility Study Success,” a best practices roadmap for navigating EFS complexities, including regulatory, ethical and legal considerations. The Blueprint covers topics including interactions with FDA, Ethics Committees and/or Institutional Review Boards (IRB)s, legal considerations including Intellectual Property (IP), and patient perspectives towards EFS.  The Blueprint is a supplement to the FDA’s Guidance on EFS/FIH Investigational Devices.  It is intended to be an overview of best practices and factors to consider for study success.