This insight brief summarizes key principles from the FDA’s draft guidance on using real-world evidence (RWE) to support medical device regulatory submissions. It explains how real-world data (RWD) sources—such as registries, electronic health records, claims, and device-generated data—can be leveraged to demonstrate safety, effectiveness, and performance across the device lifecycle. The brief emphasizes FDA expectations around relevance and reliability, including clear research questions, appropriate study design, data quality, transparency, and traceability. It discusses methodological considerations such as bias control, confounding, endpoint validation, and fit-for-purpose data selection. IQVIA highlights best practices for integrating RWE into regulatory strategies, aligning evidence

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