Early Feasibility Studies – Overview
Overview
Medical technology developers frequently conduct feasibility studies outside the U.S., delaying patient access to new technologies. The FDA’s Early Feasibility Study (EFS) initiative aims to promote early feasibility studies within the U.S., increasing patients’ access to promising technologies and supporting device innovation. MDIC supports this initiative by developing tools and best practices to enhance EFS trials and collaborating with key partners to encourage studies to focus on the U.S.
EFS Executive Steering Committee
The EFS Executive Steering Committee is essential for advancing medical device innovation in the United States. As a key part of MDIC’s support for the EFS program, this committee offers high-level direction and oversight for EFS activities.
Early Feasibility Study Programs
Neurovascular
Streamlines neurovascular clinical research in the U.S. by fostering collaboration between industry sponsors, leading clinical sites, and other stakeholders to enhance early-stage device innovation.
Biocompatibility
Electrophysiology Collaboratory (EPC)
Enhances electrophysiology EFS efficiency by collaborating with government agencies and Stanford’s Center for Arrhythmia Research to address challenges, broaden participation, and improve preparedness, accelerating patient access to innovative treatments.
Clinical Site Alliance
Streamlines EFS study start-up by uniting experienced sites in a collaborative network, aiming to provide “First-in-World” access for U.S. patients to innovative medical devices and therapies.s.
Accelerate EFS Toolkit
MDIC’s work within the EFS program includes developing tools and best practices for EFS sponsors and clinical researchers. All resources and tools within the Accelerate EFS toolkit have been compiled by a team of subject matter experts and key opinion leaders, ensuring the recommendations is rooted in deep knowledge and practical experience.
Shape the Future of EFS
Are you sponsoring a small clinical study? MDIC is tackling challenges like IRB delays and contract negotiations by collecting metrics from sponsors to improve the process and accelerate innovation. Share your insights to help advance safe, effective devices for patients.