IVD RWE Education Series Module 1: Application of the MDIC IVD RWE Framework

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.

Module 1 Overview

This module covers:

• Study design considerations for an IVD clinical performance study using real-world data (RWD) to support a premarket submission
• A step-by-step comparison of traditional IVD clinical study (wet study) design and a study design that uses RWD (dry or virtual study) for a hypothetical IVD
• How to address missingness in RWD

Audience

Sponsors and regulators who want to use RWD and real-world evidence (RWE) in regulatory submissions.