| | Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation. For sponsors of medical products, providing data from prospective randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of a regulated product. However, for many medical devices, practical limitations related to the device or disease condition require alternative approaches to prospective randomized controlled trials and increased flexibility in trial design and statistical analysis. Advances in the availability of real-world data (RWD) sources – such as electronic health records, registries, medical claims, pharmacy data and feedback from wearables and mobile technology – have increased the potential to generate robust real-world evidence (RWE), to support FDA regulatory decisions. RWE is the clinical evidence regarding the usage, and benefits and risks, of a medical product derived from the analysis of RWD. The real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users. | | | |
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