FDA Webview

Free FDA Notices

Guidance on Real-World Evidence to Support Device Decisions


Federal Register Notice: FDA is making available a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices. The agency is issuing this draft guidance to clarify how it evaluates real-world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. To download this guidance, click here. To view this notice, click here.