This Blueprint is one of the MDIC projects addressing the existing barriers for EFS. It can be considered a 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.
Appendix 1: Sample Informed Consent Template (Updated 11-JUN-2018)
Appendix 2: Sample Clinical Study Agreement Template
Appendix 3: Pugh Matrix