August 24, 2020

MDIC’s Clinical Diagnostics program today released the final version of its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access 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.

View the framework here. Read the full press release here.

MDIC provided an update of this framework on Thursday, September 10, 2020 as part of the Annual Public Forum virtual series. View the recording here.