MDICx: IVD RWE Draft Framework Public Comment Q&A

May 28, 2020, 12 p.m. ET/ 11 a.m. CT/ 9 a.m. PT

The MDIC In Vitro Diagnostic (IVD) Real-World Evidence (RWE) Framework (“Framework”) was established following the release of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which focuses on the use and potential value of RWE to support regulatory decision-making for medical devices. In the RWE Guidance, FDA notes that such evidence may be created from real-world data (RWD) through the use of appropriate methods and recommends that parties wishing to use RWE contact the FDA regarding the submissions using RWE. The Framework builds off of this by providing additional contextual information to help industry and FDA consider when and how RWD, appropriate designs, and statistical methods including modeling to generate RWE might be incorporated into product development and regulatory decision-making, particularly in support of clearance or approvals of IVDs. Although RWE has been used by FDA for years in many different contexts across the Total Product Life Cycle (TPLC), there is less experience with RWE across the range of IVD devices, especially in pre-market regulatory decision-making. This framework focuses on issues pertinent to clinical validation of RWD in pre-market and post-market regulatory decision-making of IVD devices.

Key topics include:

  • What IVD RWD is and how IVD RWE is generated
  • Whether or not to incorporate RWE into pre-market regulatory decision-making for IVDs
  • How to use RWE, when appropriate, for pre-market and post-market regulatory decision-making for IVDs
  • Specific considerations applicable to use of RWE for IVDs in this context
  • The process for providing comments during the public comment period


  • Wendy Rubinstein, MD, PhD, Director, Personalized Medicine, FDA | CDRH | OHT7:OIR
  • Danelle Miller, JD, VP, Global Regulatory Policy and Intelligence, Roche Diagnostics | MDIC IVD RWE Working Group Chair
  • Tyler O’Neill, DVM, MS, PhD, Clinical Science Leader, Acute Care, Roche Diagnostics | MDIC IVD RWE Working Group Member