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This article was originally published in The Gray Sheet

Executive Summary

The Center for Devices and Radiological Health's office of compliance and surveillance plans to complete a reorganization that would structure the office according to product areas by May 10, center staffers say. OCS has appointed acting division directors and branch chiefs and plans to complete staff assignments under the new structure by April 28. The office also must write statements describing the functions of the new divisions; OCS execs are in the process of reviewing proposed function statements that were submitted by division directors the week of April 5. Initially proposed in December 1992, the reorganization plan includes creation of three enforcement divisions, a bioresearch monitoring division and a program operations division ("The Gray Sheet" Dec. 14, p. 2). Each enforcement division will carry out compliance functions for product areas under its jurisdiction (see box, p. 8). OCS received approval from CDRH Director Bruce Burlington to go ahead with the proposal the week of March 29 and released the restructuring plan on April 6. In addition to improving effectiveness of OCS activities, the new structure could facilitate development of guidance documents by the office, according to CDRHers. Device center staffers say that OCS may be able to develop more device-specific guidance because of increased staff expertise in particular product areas. The latest version of the OCS restructuring scheme contains several changes from the original draft. The most prominent among them is the absence of a postmarket surveillance section. The center is undecided as to whether the program should remain as a separate office within OCS or be moved to the office of training and assistance, staffers say. Postmarket surveillance activities, such as analysis of adverse incident reports, traditionally have been an OCS responsibility, and the initial draft of the restructuring plan included PMS as an OCS function. However, a revision to the plan reportedly would have moved postmarket surveillance to OTA ("The Gray Sheet" March 22, In Brief). Other changes from the original plan include the creation of a separate promotions and advertising policy section. The section will be directed by Byron Tart, who currently heads OCS' labeling compliance branch. The new structure initially will be implemented for a 120-day pilot period, which is likely to be extended for another three months. After the trial period, OCS will evaluate the effectiveness of the new structure and decide whether to implement it on a permanent basis.

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