Early Feasibility Studies – Overview
Overview
Medical technology developers often conduct feasibility studies outside the U.S., which delays patient access to new technologies. The FDA’s Early Feasibility Study (EFS) facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. MDIC supports this initiative by developing tools and best practices to improve EFS trials and by collaborating with key partners to encourage studies to consider 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.
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.