In this session we will hear directly from FDA on the current status of the EUA program and how to efficiently navigate the EUA process. In addition, the session will present an industry example of how to handle design changes after EUA is granted, some of the barriers to converting from EUA to direct de novo or 510(k) clearance, and how to plan an efficient regulatory strategy towards IVD marketing clearance. This presentation includes lessons learned by one company that successfully navigated these processes.
Describe the differences in EUA requirements vs. IVD clearance requirements.
Plan how to leverage EUA studies towards direct de novo or 510(k) clearance.