PREVIEW: Early Feasibility Studies Playbook
Gathering Community Feedback Before Final Release
Pre-Release Document – Not for Public Distribution
This document is a pre-release draft and is provided for review purposes only. It is not intended for public use, publication, or dissemination. MDIC welcomes and appreciates feedback on this pre-release document.
Overview
This playbook summarizes key considerations related to EFS regulatory and operational planning, site selection, site reimbursement structures and contracting, and broader ecosystem factors influencing early-stage device evaluation. Developed for sponsors, investigators, research institutions, and clinical partners and informed by insights from the past decade of EFS clinical trials, this resource aims to support the consistent, high quality conduct of EFS programs across diverse organizational settings while ensuring that studies are executed in a manner that is both efficient and resource-conscious.
Appendices
EFS Budgeting Template
Site Feasibility and Qualification Information
EFS-FDA Engagement Checklist