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This Blog Post was originally published on FDA.gov
Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices
By: Daniel Caños, Ph.D., MPH, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH) and Michelle Tarver M.D., Ph.D., Director, CDRH
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’s first guidance on RWE was issued by the FDA’s Center for Devices and Radiological Health (CDRH) in 2017. It provided clarity on how CDRH evaluates the relevance and reliability of RWD to support medical device regulatory decision-making. In 2019, CDRH published a set of 90 examplesExternal Link Disclaimer of different types of premarket submissions supported by RWE. Then, in December of 2025, CDRH issued an update to the RWE guidance entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” That guidance explains how the least burdensome approach applies to assessing whether RWD are relevant and reliable for marketing decisions, such as expanded indications for use or clearance or approval of new devices. It also describes recommended methods for using RWE and provides considerations and best practices for FDA review.
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