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 Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices 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. Food and Drug Administration 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. The FDA has published a new set of 73 examples of marketing authorizations using RWE from FY2020-2025, building on the foundational work presented in the 2021 publication "Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions." The FDA is redoubling efforts to utilize RWE across a wider range of medical devices to support timely access to safe and effective technologies, foster innovation, and strengthen the foundation of regulatory decision-making.