Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices

https://www.fda.gov/news-events/fda-voices/real-world-evidence-advancing-regulatory-decision-making-medical-devices?utm_medium=email&utm_source=govdelivery Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data (RWD) generates relevant and reliable Real-World Evidence (RWE). The U.S. FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence. RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. Appropriately validated RWE can support a broad range of regulatory activities, including serving as the primary clinical evidence in premarket submissions.