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# FDA Wants to Be 1st to Find Device Safety Signals
- URL: https://www.fdaweb.com/fda-wants-to-be-1st-to-find-device-safety-signals/
- Published: 2018-11-20T12:00:00.000Z
- Updated: 2026-09-15T00:45:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142889

In a joint statement, FDA commissioner **Scott Gottlieb** and CDRH director **Jeffrey Shuren** say they have a new medical device safety goal: to ensure that FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. Their [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626286.htm?ref=fdaweb.com) also discusses new funding for the National Evaluation System for Health Technology (NEST), the launch of pilot studies to demonstrate how NEST would be implemented, and advances in developing a women’s health coordinated registry network to help strengthen NEST. 

Gottlieb and Shuren say the new safety goal is “a culmination of steps that the agency has taken in recent years to strengthen and implement new post-market monitoring tools to adequately assess device performance and patient safety in real time. In many cases, we already have been the first to act on or identify and act on safety signals. But as we continue to look to the future, we aspire to build on the foundation that we’ve laid in recent years to become ‘consistently’ first. We’re evolving beyond our current post-market surveillance system, which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We’ve moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information.”

The two say there is already evidence that NEST will help improve the breadth and quality of real-world evidence that can be accessed and analyzed. So the agency is committing more resources to the project to advance a more rapid build-out of the system. 

The statement says the agency’s budget request for 2019 includes an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. “If this funding becomes a reality,” they say, “FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term.” 

The statement also references efforts to strengthen Coordinated Registry Networks that link different real-world data sources to generate clinical evidence about medical products used by patients. A particular focus is clinical questions on device therapies that are unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilization, and long-acting reversible contraception.