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