MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 24, 2024


12:05 pm


1:30 pm

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