Examples of Real-World Evidence Used in Medical Device Regulatory Decision-Making (2020-2025)
In April 2026, the U.S. Food and Drug Administration (FDA) published 73 new examples of real-world evidence (RWE) used in medical device regulatory decisions from fiscal years 2020–2025. These examples highlight the expanding range of data sources, device technologies, and regulatory applications supported by RWE. This collection builds on the FDA’s original 90 examples from fiscal years 2012–2019, published in 2021, providing a broader view of how RWE has informed medical device regulatory decision-making over time. Explore the 2012–2019 examples.
Real-World Data (RWD)
Real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. These include, but are not limited to, electronic health records (EHRs), claims, registries and patient-generated data.
Real-World Evidence (RWE)
Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.
Number of RWE Examples
In April 2026, the U.S. Food & Drug Administration (FDA) published a selected set of examples of medical device regulatory submissions using RWE. While not inclusive of all submissions or regulatory decisions that used RWE, the sample showcases the various uses of RWE as valid scientific evidence.
By Device Type
By Regulatory Pathway
By Area of Specialty
Average Time to Review
Calculated separately for each pathway. Values shown in months.
EXAMPLES BY YEAR RECEIVED
Please note: Review times are based on regulatory application receipt and decision dates. RWE may have been applied after clearance or approval, including as part of post-approval requirements. Examples are illustrative and not exhaustive.
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