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OCS restructuring

This article was originally published in The Gray Sheet

Executive Summary

Topsiders from the office of compliance and surveillance in FDA's Center for Devices and Radiological Health formulate restructuring plan that calls for transfer of postmarket surveillance activities from OCS to CDRH's office of training and assistance. The plan has been forwarded to CDRH Director Bruce Burlington, who is expected to sign off on it during the week of March 22. The plan also would restructure OCS' remaining operations along product lines. Late last year, OCS management floated a restructuring proposal that would have kept PMS duties in OCS ("The Gray Sheet" Dec. 14, p. 2).
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