IVD RWE Education Series

The purpose of this series is to provide education on key aspects related to using real-world evidence (RWE) in regulatory submissions. The series expands upon the content presented in the Medical Device Innovation Consortium (MDIC) In Vitro Diagnostic (IVD) RWE Framework.

The modules are based on webinars created by Marina Kondratovich, Ph.D., associate director for clinical studies in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).

Module 1 Webinar: