The Medical Device Innovation Consortium (MDIC) has launched a new Clinical Diagnostics (CDx) series to assist healthcare stakeholders in the design of real world data (RWD) studies. The program also details considerations for successful in vitro diagnostic (IVD) submissions to the Food and Drug Administration (FDA).
“Module 1 of MDIC IVD RWE Education Series the series focuses on study design considerations for an IVD clinical performance study using RWD to support a premarket submissions. 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.” Learn more here.
(Source: MDIC, 10/21)