August 23, 2020

The MDIC In Vitro Diagnostic (IVD) Real-World Evidence (RWE) 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, the 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 the 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 the 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 premarket regulatory decision-making.

This framework focuses on issues pertinent to clinical validation of RWD in premarket and postmarket regulatory decision-making of IVD devices.

To oversee this project, MDIC formed an IVD RWE Working Group consisting of subject matter experts from MDIC’s diagnostic member organizations supplemented with experts in regulatory science and policy, epidemiology, and biostatistics from government and other organizations. For a list of the Working Group members, please refer to the Authors page at the beginning of the Framework.

This Framework contains a summary of all elements of the Working Group’s approach. Additional content can be found here.