News | April 07, 2010

Medical Manufacturer Says it Corrected FDA Reporting Issues

April 7, 2010 – The U.S. Food and Drug Administration (FDA) recently sent a warning letter to Edwards Lifesciences Corp. for late reporting of adverse events with its medical devices.

The letter contains one observation related to six incidences of late medical device reporting (MDR). The MDR is a mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. The late MDR reporting ranged from six to 29 days beyond the 30-day reporting requirement.

FDA inspectors found the reporting problems in September 2009 when it inspected Edwards' facility in Irvine, Calif. The company's training procedures on the MDR reporting process were corrected during the inspection and discussed with the FDA. The FDA subsequently issued its establishment inspection report (EIR) in October 2009 concluding its inspection.

Edwards does not expect this matter to have any impact on product approvals.

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