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) explained the goals of the EFS pathway and shared practical strategies for moving from concept to clinical trial.
Through presentations and a panel discussion with leading clinicians, attendees gained insight into key regulatory considerations, development milestones, and lessons learned from real-world experience.
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; Christopher M. Owens, MS, MBA; 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, MS - FDA
Panel Discussion
Navigating Early Device Development: From Idea to Trial
Christopher M. Owens, MS, MBA
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
