FDA Turns Adverse-Event Reporting Scrutiny On Hospitals
The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.
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A public-private National Evaluation System for health Technology (NEST) is gathering momentum following a recent funding agreement in the draft Medical Device User Fee Act IV deal. A planning board tasked with developing a NEST coordinating center has outlined projects to get the system off the ground. Also: Listen to our podcast interview with Mark McClellan about the project.