Accelerate EFS Toolkit

The FDA’s Center for Devices and Radiological Health (CDRH) launched the Early Feasibility Study (EFS) program to prioritize First-in-World patient access to innovative technologies with significant health benefits. In alignment with this goal, the FDA issued its final Guidance in October 2013, titled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.

Recognizing that early-stage support is crucial to fostering medical device innovation and access for U.S. patients, MDIC advances this CDRH priority through its EFS Initiative. We’ve developed a comprehensive EFS Toolkit featuring essential tools and best practices designed to support broad participation in the EFS program. Explore the Accelerate EFS Toolkit to discover how these resources can facilitate your collaboration with the FDA, industry, providers, and other stakeholders.