Accelerate EFS Toolkit
Early Feasibility Studies Playbook
The Early Feasibility Studies 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.
MDIC EFS Explorer
Built on information from ClinicalTrials.gov, EFS Explorer centralizes key data and resources related to Early Feasibility Studies. This game-changing new tool empowers sponsors, sites, and other stakeholders identify and engage with qualified sites experienced in EFS.
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The Early Feasibility Studies 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.
This fillable PDF template supports site qualification and feasibility. Sponsors and CROs should use this information to populate feasibility forms or surveys and avoid duplicating requests. Any information not included here can be provided upon request.
The checklist provides a structured guide for sponsors developing medical devices under the FDA Early Feasibility Study (EFS) Program to enhance regulatory interactions and development planning. It emphasizes early and continuous FDA engagement, clarifying EFS goals, and preparing thorough submissions to support downstream decisions.
- It encourages defining the clinical context, device evolution, testing strategies, and risk mitigation with reference to FDA guidance.
- Sponsors are advised to engage FDA before costly testing and major submissions, maintaining clear, respectful communication and documentation.
- The checklist aims to reduce regulatory friction while ensuring patient safety and effective data use in later development stages.
This Early Feasibility Study (“EFS”) Clinical Trial Agreement template is provided by The Medical Device Innovation Consortium (“MDIC”) as an educational tool. It is neither intended, nor should be considered, to be legal advice. Applicable laws may vary in different states. Also, federal and state laws governing clinical studies are subject to change and to varied interpretations by courts in different jurisdictions. Each Institution and Sponsor entering into a clinical study agreement should consult with its own counsel to obtain legal advice on contracts for clinical studies.
The following template is provided to support the process and structure for EFS budget development.
This fillable table supports the building of effective and comprehensive EFS teams.
Consent Tools
The “Introduction to Consent for Early Feasibility Studies for Patients” document addresses patient questions and needs. It explains what it means to participate in an EFS and emphasizes the importance of patient understanding. It is an educational aid provided before presenting the Informed Consent Form (ICF), which details the EFS, associated risks, and trial specifics.
Cardiology Research at Columbia University Irving Medical Research Center developed this screening consent form document as an alternative to a full consent process for studies where anatomy plays a key part in inclusion/exclusion. This allows their team to send standard-of-care images and data to sponsors to determine eligibility before we conduct a full consent process with the patients.
EFS Informed Consent Form – Primary Template
Alternative Language Translations:
Bengali
Chinese (PRC)
Chinese (Taiwan)
Gujarati
Hindi
Japanese
Korean
Tagalog
Telugu
Urdu
Vietnamese
Additional Tools
This tool simplifies contracting for clinical trials, focusing on trials that have received IDE approval through the EFS program within CDRH. The Negotiation Tool sets up a process to prevent proposing negotiation positions likely to be rejected by the other party before discussions begin. The EFS Language Libraries facilitate customization of the recommended Key Terms and Conditions in the proactive Negotiation Range process.
This document is directed to patient advocates and describes what it means for a patient to participate in an EFS.
A best practices guide for navigating EFS complexities, including regulatory, ethical, and legal considerations. Developed as a supplement to the FDA’s Guidance on EFS/FIH Investigational Devices, the EFS Blueprint addressed topics including FDA interactions, Ethics Committees and/or Institutional Review Boards (IRB)s, legal considerations, and patient perspectives.