Zdrowie i gospodarka · 27/07/2016

FDA Releases Draft Guidance on Real-World Evidence for Medical Devices

The Food and Drug Administration (FDA) has released a draft guidance on using real-world data to support regulatory decisions for medical devices, outlining how to evaluate and utilize real-world evidence in device approvals. The guidance aims to clarify the use of real-world data and investigational device exemptions for device safety and effectiveness evaluations.