Happy Days Are Here Again: A Review of Fiscal 2007–09 Device Research Warning Letters

Posted 01 July 2010 | By

Eleanor Roosevelt once said, "Learn from the mistakes of others. You can't live long enough to make them all yourself." Apparently, the medical device research community has been learning from previous mistakes, as the most recent US Food and Drug Administration (FDA) compliance trends indicate that fewer Bioresearch Monitoring Warning Letters (WLs) are being issued to the regulated device research community. An analysis of Fiscal 2007 WL patterns for the device research community published in the Medical Device and Diagnostic Industry provides a baseline to discern trends in WL data.1

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