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CDRH ombudsman’s report

This article was originally published in The Gray Sheet

Executive Summary

Number of contacts received by CDRH Ombudsman Les Weinstein in 2004 grew to 125, up from 120 in 2003, according to the 1ombudsman's annual report. Industry accounted for 90% of 2004 contacts, compared with 78% in 2003 (2"The Gray Sheet" April 5, 2004, p. 8). The Office of Device Evaluation remains the office most often involved with disputes/complaints (66%). Premarket notifications are still the most cited subject for disputes/complaints (28%), while inspections (4%) and HDEs (2%) were added to the list for the first time in 2004. Miscommunication or lack of communication continues to be the top reason for complaints/disputes (25%), followed by "least burdensome" issues (16%). By the end of 2004, about 35% of complaints/disputes were pending, 31% resolved, 21% withdrawn or not followed-up and 13% referred outside CDRH. In 2003, 26% were resolved and 22% were pending...

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