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# NEST Real-World Evidence Activities Updated
- URL: https://www.fdaweb.com/nest-real-world-evidence-activities-updated/
- Published: 2019-03-20T12:00:00.000Z
- Updated: 2026-09-15T01:14:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143661

The National Evaluation System for health Technology (NEST) has test cases underway to demonstrate proof-of-concept for generating robust real-world evidence (RWE) in preparation for regulatory submissions such as label expansions or to meet postmarket surveillance requirements. Writing in a *Clinical Pharmacology & Therapeutics* [commentary](https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1380?ref=fdaweb.com), CDRH director **Jeffrey Shuren** says the test cases started in 2018 and that those starting this year will include an additional focus on using real-world data (RWD) and real-world evidence for active surveillance.

“The potential for RWD and RWE to accurately detect safety signals has been discussed for several years,” Shuren writes. “The access to large databases owned by health systems collaborating together and coordinated registry networks is opening up new possibilities for active surveillance of medical devices.”

He says NEST is in the early stages of establishing a network of organizations to support increasing numbers of high-quality RWE studies. “The test cases will provide important lessons for the medical device ecosystem on the practical and scientific challenges of conducting RWE medical device studies,” he concludes.