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FDA to kick off Sentinel system with preliminary model by July

This article was originally published in The Silver Sheet

Executive Summary

Post-market data on medical devices won't be immediately tracked under FDA's new "mini-Sentinel" project, the agency says. The system was mandated by the 2007 FDA Amendments Act, which requires the agency to establish by July 1 an active surveillance program to identify and analyze drug safety data from multiple sources, such as insurance claims data and electronic health records ("The Silver Sheet" June 2008). At a Jan. 11 public workshop in Washington, D.C., experts questioned how easily FDA could scale up the preliminary model to a stronger Sentinel, which would encompass more product areas and data. Mini-Sentinel will provide a testing ground for the type of data sharing and analysis envisioned in the law, and will focus on drug safety surveillance for at least one year before being expanded to other product areas, says Janet Woodcock, director of FDA's drug center. Unlike with drugs, which are identified by unique National Drug Codes, a key challenge for devices will be: "How do you identify which device is put into someone?" Woodcock says. Some in industry have suggested that a unique device identification (UDI) system will need to be in place to make Sentinel feasible for devices
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