The Sentinel System will bolster the FDA’s efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine healthcare, such as data from electronic health record systems, administrative and insurance claims databases and medical registries.
Read the news release about the FDA’s Sentinel System.
Read other coverage about medical devices:
– AAMI Urges Federal Agencies to be More Engaged in Developing Medical Device Standards
– FDA Proposes Medical Device Innovation Initiative
– Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
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