April 24, 2024
Harnessing the Power of Pre-Submissions and Clinical Evidence
Pre Market Track
In the last few years, FDA has issued several guidance documents related to evidence generation for medical devices. This session is designed to explore these guidances, offering attendees a road map for leveraging pre-submissions and clinical evidence to achieve a streamlined and expedited approval/clearance process.
Shannon Hoste, Vice President, Human Factors Engineering, Agilis by Kymanox
Daniel Canos, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA