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# FDA Exploring New Device Active Surveillance System
- URL: https://www.fdaweb.com/fda-exploring-new-device-active-surveillance-system/
- Published: 2023-02-23T12:00:00.000Z
- Updated: 2026-09-14T18:16:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153844

FDA has published a “sources sought” information request to survey potential contractors on their expertise and capabilities to develop and implement a medical device active surveillance system involving electronic health record (EHR) data to better understand device safety within clinical practice settings.

The agency says the primary need for an active surveillance system is “signal detection to identify new potential risks or changes in known risks that may meaningfully affect a technology’s benefit-risk profile. Such signals, if confirmed, often warrant taking steps to the mitigate the signal.”

Such a system should “optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner,” an [agency notice](https://content.govdelivery.com/accounts/USFDA/bulletins/34a70d8?ref=fdaweb.com) says. “The active surveillance program is focused around achieving better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings.”

FDA says it is seeking information from potential contractors to “inform the next evolution of the medical device active surveillance system. The FDA anticipates establishing a contract for the development and execution of a medical device active surveillance system to vendor(s) with the appropriate expertise to design, develop, and run such a system.”

One area FDA is interested in learning more about from potential contractors is their “capability to incorporate natural language processing (NLP), federated learning, machine learning (ML), and/or artificial intelligence (AI) methods to robustly identify adverse events and potential device safety signals in linked medical claims and EHR data.”

Responses on the sources sought request are due by 3/20.