Disclosure Statement

The Sentinel System is sponsored by the U.S. Food and Drug Administration (FDA) to proactively monitor the safety of FDA-regulated medical products and complements other existing FDA safety surveillance capabilities. The Sentinel System is one piece of FDA’s Sentinel Initiative, a long-term, multi-faceted effort to develop a national electronic system. Sentinel Collaborators include Data and Academic Partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise. The Sentinel Coordinating Center is funded by the FDA through the Department of Health and Human Services (HHS) Contract number HHSF223201400030I. This project was funded by the FDA through HHS Mini-Sentinel contract number 75F40119D10037.