October 12, 2021

MDIC’s Clinical Diagnostics Program has launched a new educational series to help sponsors and regulators who want to use real-world data (RWD) and real-world evidence (RWE) in in vitro diagnostic (IVD) regulatory submissions.

Module 1 of the MDIC IVD RWE Education Series the series focuses on study design considerations for an IVD clinical performance study using RWD to support a premarket submission.

These educational modules present practical applications of the MDIC IVD RWE Framework and serve as companion guides to webinars created by Marina Kondratovich, Ph.D., associate director for clinical studies in the Office of In Vitro Diagnostics and Radiological Health at the US Food and Drug Administration Center for Devices and Radiological Health.