International – Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics

The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs). Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be incorporated into product development and regulatory decision-making in support of clearance or approvals of IVDs. It also outlines considerations for appropriate designs and statistical methods for generating real-world evidence (RWE) for regulatory submissions…