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US OIG report criticises FDA’s use of adverse event reports

This article was originally published in RAJ Devices

Executive Summary

The US Department of Health and Human Services’ Office of Inspector General recommends that the Food and Drug Administration improve how it uses adverse event reports for medical devices to identify and address safety concerns. The OIG’s recommendations are based on its findings of a review of adverse event reporting from 2003 to 2007, which was published in October 20091.

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