New FDA initiatives and recent 510k recommendations from the Institute of Medicine raise uncertainties for companies seeking medical device marketing approval.
This program addresses two timely issues:
- Changes to device regulatory pathways, particularly 510k clearance, and how industry should best prepare to interact with the FDA;
- Benefits and challenges of accelerating product development by conducting studies, or obtaining regulatory approvals, in Europe prior to US approval.
- Daniel Schultz, M.D.
- Senior Vice President, Medical Devices and Combination Products, Greenleaf Health
- Former Director, Center for Devices and Radiological Health (CDRH)
- Heather Rosecrans
- Senior Regulatory Advisory, Greenleaf Health
- Former Director, 510(k) Pre-Market Notification Staff
- Brian Duncan, M.D., M.B.A.
- Vice President, BioEnterprise and Ohio Venture Partner, Arboretum Ventures
- Ray Ursick
- President, REU Associates
- Neal Defibaugh
- VP Clinical and Regulatory Affairs, AxioMed Spine