Selected examples with file summaries, details on real-world data source, populations, and descriptions of use


Real-world data (RWD) can be collected from a diverse array of sources, such as electronic health records, registries, administrative claims, pharmacy data and feedback from wearables and mobile technology. These data offer opportunities to generate evidence and better understand clinical outcomes.

In support of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) mission to protect and promote public health by ensuring the safety and effectiveness of medical devices, while assuring patients have timely access to them, CDRH aims to foster the use of real-world evidence (RWE) to support regulatory decision-making. To further this goal, by developing a more complete understanding of RWE usage, CDRH has reviewed a sample of past decisions to identify examples leveraging RWE in premarket and postmarket decisions.

We selected a set of 90 examples of submissions that illustrate the broad spectrum of RWE usage in support of regulatory decision-making from fiscal years 2012 through 2019.


FDA offers real-world evidence examples in device applications