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Adverse Events Reported To FDA Under MDR Program Ballooned 77% In 2006

This article was originally published in The Silver Sheet

Executive Summary

LAST YEAR'S RISE IN MEDICAL DEVICE REPORTS may have been the result of more products on the market, as well as increased compliance with reporting regulations, CDRH's Office of Surveillance and Biometrics says. More than 325,000 adverse events were reported to the agency's MDR program in calendar year 2006 - an all-time high - and OSB staffer Indira Konduri expects the trend to continue. “At some point I'm sure it will plateau, but it definitely does look like this year and next, for sure, we'll probably see an increase,” Konduri says, noting that device recalls also may have played a part in the large volume of MDRs. Meanwhile, FDA clarifies MDR reporting requirements in a warning letter to Medtronic
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