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# 10-Year History of Sentinel System
- URL: https://www.fdaweb.com/10-year-history-of-sentinel-system/
- Published: 2019-06-04T12:00:00.000Z
- Updated: 2026-09-15T01:30:35.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5144253

A [presentation](https://www.sentinelinitiative.org/sites/default/files/communications/publications-presentations/2019-05-23%5FISPE%5FWebinar.pdf?ref=fdaweb.com) by staff from FDA and Harvard Medical School on “Medical Product Safety: Ten Years of the U.S. Sentinel System” gives the history and operations of the Sentinel System. FDA uses Sentinel to: **(1)** evaluate safety signals identified during the premarket review of new drug applications; **(2)** evaluate safety signals identified during the postmarket period; and **(3)** identify new potential safety signals during the postmarket period.

The presentation describes Sentinel as FDA’s medical product active safety surveillance system intended to assess the use, safety, and effectiveness of regulated medical products, and develop data, informatics, and methodologic capabilities to support the activities.

Key system components are a distributed data network of 18 data partners, electronic healthcare data, common data model, and sophisticated quality assurance process.