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10/23/2009: OIG Report on FDA CDRH PDF Print E-mail
Written by Joshua I Rozovsky   
Friday, 23 October 2009 18:43

On October 23, the OIG released a report entitled "Adverse Event Reporting for Medical Devices (OEI-01-08-00110)." In its report the OIG found that "...the Center for Devices and Radiological Health (CDRH) does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices." The report can be found here.

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