Welcome to Mini-Sentinel

Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to create an active surveillance system - the Sentinel System - to monitor the safety of FDA-regulated medical products. Mini-Sentinel uses pre-existing electronic healthcare data from multiple sources. Collaborating Institutions provide access to data as well as scientific and organizational expertise. Mini-Sentinel is part of the FDA’s Sentinel Initiative, which is exploring a variety of approaches for improving the Agency’s ability to quickly identify and assess safety issues.

Most Mini-Sentinel activities focus on assessments, methods, or data. Visit the following links to learn more about each type of activity:

  • Assessments - Medical product exposures, health outcomes, and links between them
  • Methods - Techniques for identifying, validating, and linking medical product exposures and health outcomes
  • Data - Mini-Sentinel Distributed Dataset and tools used to access the data

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel Pilot in the public domain as soon as possible. FDA will continue to communicate information about the safe use of medical products using existing channels, such as FDA’s press announcements, MedWatch Alerts, Drug Safety Communications, and Safety & Availability (Biologics) Communications. For more information please visit FDA at www.fda.gov.

Information obtained through Mini-Sentinel is intended to complement other types of data and information compiled by FDA scientists, such as adverse event reports, published study results, and clinical trials, which can be combined with Mini-Sentinel data and used by FDA to inform regulatory decisions regarding medical product safety. FDA may access the data available through Mini-Sentinel for a variety of reasons beyond assessing potential safety risks for a specific product (e.g., estimating the background rate of health outcomes, examining medical product use, and evaluating research methods). 

Please also visit Mini-Sentinel Disclaimer

Page Updated: 10/15/2014