This whitepaper is the result of a collaborative effort of the Medical Device Innovation Consortium (MDIC), the medical device industry, strategy consultants, and the Food and Drug Administration (FDA). It brings together their perspectives and cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The paper summarizes the initial findings and recommendations developed by the joint team, including a proposed framework for risk-based improvement. We recommend that industry participants test the framework in a live pilot. This paper does not constitute advocacy or lobbying or present recommendations on policy or political matters. Moreover, although FDA representatives on the program team are supportive of the framework, this paper does not represent conclusions or policy changes by the agency.
MDIC working group outputs from the three EFS focus areas act in synergy, facilitating U.S. patient First-in-World access to novel medical technologies Medical technology ecosystem partners with experience conducting feasibility studies through the FDA/CDRH EFS Program, are invited to contribute to this effort by completing MDIC’s EFS survey.
2017 Program Summary of the work that MDIC facilitated with sponsors to analyze EFS performance metrics.
This Resource contains tools and best practices focused on those clinical trial agreement (CTA) clauses identified as the most time-consuming to negotiate, and accounts for considerations unique to EFS trials including: the novel nature of device; procedural advancements, such as surgical technique or sample acquisition; and EFS-specific (vs. other trials) clinical operations.
Published in October 2017
The Early Feasibility Study (“EFS”) Master Clinical Trial Agreement template is provided by The Medical Device Innovation Consortium (“MDIC”) as educational tools. They are 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.
EFS MCTA (PDF) (Version 2, Updated September 2019)
EFS MCTA (MS WORD) (Version 2, Updated September 2019)
A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success.
Updated June 2018 to include an editable version (MS Word) of the CF template for EFS trials.
An important aspect of patient advocacy in EFS is to ensure that patients have a good understanding of EFS. The ICF provides details on EFS, as well as an overview of the risks associated with the specific device and EFS trial. To aid with the education of patients who may be eligible for a specific EFS, a brief “Patient Introduction to Consent for Early Feasibility Studies” has been created. This document focuses specifically on what it means to the patient to participate in an EFS. The Patient Introduction is an educational aid provided to the patient prior to presentation of the ICF.
When hospital administration, research staff and IRB members have a good understanding of EFS, the time to complete study contracts, IRB approvals and patient screening and enrollment are likely to decrease. To aid with the education of these stakeholders, a brief “Background Information on Early Feasibility Studies” has been created. This document is directed to patient advocates and describes what it means for a patient to participate in an EFS.