Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative.
Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing Adverse Event Reporting System. Through Sentinel, the FDA can rapidly and securely access information from large amounts of electronic healthcare data, such as electronic health records (EHR), insurance claims data and registries, from a diverse group of data partners. Sentinel uses a distributed data approach which allows the FDA to monitor the safety of regulated medical products, while securing and safeguarding patient privacy.