The FDA’s Early Feasibility Study (EFS) Program helps bring breakthrough medical devices to patients faster by enabling earlier clinical evaluation in the United States. In this one-hour webinar, experts from the FDA, industry, and the Medical Device Innovation Consortium (MDIC) will explain the goals of the EFS pathway and share practical strategies for moving from concept to first-in-human study.
Through presentations and a panel discussion with leading clinicians, attendees will gain insight into key regulatory considerations, development milestones, and lessons learned from real-world experience.
What you’ll learn:
- The purpose and structure of the FDA’s EFS Program
- Key steps for advancing a device from concept to clinical study
- Practical insights and lessons learned from experienced leaders
Moderators: Saher Sabri, MD; Eric A. Secemsky, MD, MSc
Panelists: Donna Buckley, MD - FDA; Brian DeRubertis, MD; Andrew Farb, MD - FDA; Eileen Mihas, RN, MSN-HSL - MDIC; Mahmood Razavi, MD
Welcome and Introductions
Saher Sabri, MD, and Eric A. Secemsky, MD, MSc
Purpose and Overview of FDA's Early Feasibility Program for Medical Devices
Donna Buckley, MD - FDA
Panel Discussion
Navigating Early Device Development: From Idea to Trial
Industry Delegate
Panel Discussion
Case Example and Pearls for Success
Eileen Mihas, RN, MSN-HSL - MDIC
Panel Discussion
Closing remarks
Saher Sabri, MD and Eric A. Secemsky, MD, MSc
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