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# CDRH Publishes 90 Examples of Real-World Evidence Use
- URL: https://www.fdaweb.com/cdrh-publishes-90-examples-of-real-world-evidence-use/
- Published: 2021-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:51:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148900

CDRH has published an analysis of its experience in using real-world evidence (RWE) in regulatory decisions to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market. In an online [statement](https://www.fda.gov/news-events/fda-voices/leveraging-real-world-evidence-regulatory-submissions-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery), CDRH director **Jeffrey Shuren** and Office of Clinical Evidence and Analysis director **Daniel Caños** say the 90 [examples](http://www.fda.gov/media/146258/download?ref=fdaweb.com) “come from the full continuum of clinical and device areas throughout CDRH and across the medical device total product life cycle but do not comprise an exhaustive list of all submissions that have relied on RWE.”

The two report that leveraging RWE has provided CDRH with more timely access to a broader and richer set of safety information to better protect the American public and to inform the Center’s oversight of the total product life cycle. “By unleashing the power of RWE, we can accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety,” Shuren and Caños say.