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Behind The Scenes At FDA: Former CDRH Compliance Director Talks Device Recalls

This article was originally published in The Silver Sheet

Executive Summary

Tim Ulatowski, the former director of CDRH’s Office of Compliance, is concerned about the overall volume of medical devices being recalled, as well as the number of high-risk class I recalls reported by manufacturers. “Things appear to be out of control,” Ulatowski says. In an interview with “The Silver Sheet,” he opened up about his handling of class I recalls when he was in charge of the compliance office and the large recall backlog that developed during his tenure, among other topics.

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