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By: Daniel Ca\u00f1os, 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<\/p>\n
Today\u2019s 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.<\/p>\n
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Daniel\u00a0Ca\u00f1os, Ph.D.,\u00a0MPH, Director, Office of Clinical Evidence and Analysis, CDRH \u00a0<\/p>\n
The FDA has published a new set of 73 examples<\/a> 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<\/a>.” The FDA\u2019s first guidance on RWE was issued by the FDA\u2019s 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 examples<\/a> of different types of premarket submissions supported by RWE. Then, in December of 2025, CDRH issued an update to the RWE guidance entitled \u201cUse of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices<\/a>.\u201d 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.<\/p>\n The 73 new examples represent a broad spectrum of clinical and device areas throughout CDRH across the total product life cycle while demonstrating the evolving landscape of data sources used to generate RWE. However, they do not comprise an exhaustive list of all submissions that have relied on RWE, at least in part, to inform a regulatory decision. While registries have long played a central role, other data sources such as electronic health records aggregators, administrative claims and billing data, device-generated data, digital health platforms, and increasingly sophisticated data linkages, are contributing to a broader and more dynamic evidence environment.<\/p>\n These new examples also highlight the growing use of RWD to validate device software functions, including artificial intelligence (AI) and machine learning (ML)-enabled technologies. For instance:<\/p>\n Michelle Tarver, M.D., Ph.D.<\/p>\n The FDA relied on retrospective medical record data generated during intensive care unit patient stays to support clearance of an ML-based software function to predict hemodynamic instability (K200717<\/a>). The ICU-generated data came from the evaluation of device performance using physician-reviewed records as the reference standard.The FDA evaluated the validation of two separate AI-enabled electrocardiogram-based software functions to support clearance of two separate premarket notifications (K250119<\/a> and K250649<\/a>) using medical record data across several geographically distributed U.S. sites. The medical record data helped the FDA compare device output against echocardiogram-derived left ventricular ejection fraction measurements obtained in routine clinical practice.The FDA evaluated automatic event detection software for polysomnography using archived sleep recordings from routine clinical care. As part of the evaluation, the FDA compared device output to clinician manual scoring of the same studies. These data supported clearance of the premarket notifications K241960<\/a> and K221179<\/a>.<\/p>\n These examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas. \u00a0<\/p>\n 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. We also continue to work with the National Evaluation System for health Technology (NEST)<\/a> to assess and identify high-quality RWE sources that can be used for regulatory purposes. This comprehensive approach will enable more robust and efficient use of RWE to characterize the performance of medical devices in real-world settings.<\/p>\n We invite interested parties to review these examples to gain a better appreciation of how widely applicable RWE has been and can be.\u00a0<\/p>\n Content current as of:<\/p>\n 04\/02\/2026<\/p>\n","protected":false},"excerpt":{"rendered":"Image By: Daniel Ca\u00f1os, Ph.D., MPH, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological…\n","protected":false},"author":2,"featured_media":565187,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[97,252,253],"class_list":["post-565186","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-care","tag-health","tag-health-care","tag-healthcare"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/565186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=565186"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/565186\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/565187"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=565186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=565186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=565186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"Michelle](\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/04\/Michelle_Tarver_900x900.png\" "\\"Michelle_Tarver-900x900\\"")
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