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

February 17, 2024 | Clinical Diagnostics

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.

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