HHS report faults FDA's device center over use of adverse event reports

10/29/2009 | Modern Healthcare (free registration)

The FDA's Center for Devices and Radiological Health failed to efficiently use reports of serious adverse events linked to medical devices to act on safety concerns despite the increase in such reports received by the agency between 2003 and 2007, according to a study by the HHS Office of Inspector General. The office advised the device center to set up a system that would record and monitor the actions initiated to solve adverse events.

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