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OCS restructuring

This article was originally published in The Gray Sheet

Executive Summary

Device center's office of compliance and surveillance will reorganize on a trial basis in late March or April following Commissioner-level clearance. OCS managers floated a proposal to reorganize the office according to product areas in December 1992 ("The Gray Sheet" Dec. 14, p. 2). The plan will be implemented for a three- to six-month period, after which its effectiveness will be evaluated. FDA has not yet decided whether postmarket surveillance activities will remain within OCS or be moved to the office of training and assistance. If shifted to OTA, that office also likely would reorganize by device areas, FDAers say.
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