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Ombudsman: Quick resolution to complaints in 2006

This article was originally published in The Silver Sheet

Executive Summary

Issues surrounding product adverse events, FDA inspections, warning letters and the Quality System Regulation accounted for 12 percent of complaints filed with CDRH's ombudsman last year, according to a recently published annual report. Ombudsman Les Weinstein received a total of 120 complaints from device manufacturers and others last year - roughly the same as in the previous three years. Eighty-one percent of the cases on Weinstein's desk last year were resolved. The resolution rate was significantly lower in prior years: 33 percent in 2005, 31 percent in 2004 and 26 percent in 2003. "Last year, a lot of cases to be resolved could be resolved quickly," Weinstein says. In addition, a number of cases that came to Weinstein's attention in 2004 and 2005 were finally resolved in 2006. As in previous years, "miscommunication" or "lack of communication" was the No. 1 reason for gripes to the ombudsman in 2006

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