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This article was originally published in The Gray Sheet

Executive Summary

DEVICE CENTER'S OTA TO ESTABLISH SEPARATE MAMMOGRAPHY/RADIOLOGY DIVISION as part of a broader restructuring of the office of training and assistance. The new division will be responsible for FDA's implementation of the Mammography Quality Standards Act of 1992. Tentatively titled the division of mammography quality and radiation programs, the group will also carry out OTA's existing responsibilities in the radiology area. Under MQSA, FDA is required to develop mammography standards and oversee mammography facilities certification ("The Gray Sheet" May 10, I&W-4). OTA's current radiology duties, which are carried out by the radiology device branch of the division of technical development, include participating in the NEXT (Nationwide Evaluation of X-ray Trends) cooperative state/federal x-ray quality assurance program and coordinating inspections of federal radiology facilities. When fully staffed, the new division will be comprised of approximately 30-35 people, according to FDAers. As a result of the addition of the new division, OTA staff levels would increase to over 100. OTA currently employs approximately 80 people, not including the 8-10 who will be transferred to the new office of surveillance and biometrics ("The Gray Sheet" May 24, p. 6). The center published a recruitment announcement for a director for the mammography/radiology division the week of July 19. The new OTA structure, including the new division, is expected to be operational by Oct. 1. OTA staffers are meeting with device center Director Bruce Burlington in mid-August to discuss the restructuring effort. The restructuring is not expected to change activities of the division of small manufacturers assistance, which may actually gain a few staffers. The restructuring will, however, affect OTA's consumer and health professional programs. OTA is planning to consolidate the divisions of professional programs, technical development, and consumer affairs into one division, tentatively called the division of user programs and systems analysis. The consolidation is due in part to FDA plans to transfer some of the divisions' personnel to OSB and to the new mammography/radiology division. The three divisions currently are staffed by approximately 10-12 people each; 22 people are expected to remain in the consolidated division. The responsibilities of the consolidated division will remain consonant with the mission of the three original divisions: to provide consumer and health professional education regarding user problems. The consolidated division will continue to respond to consumer and professional inquiries, and develop generic guidances, manuals, checklists and publications to address problems identified by the division. However, the group will take on fewer activities than they have in the past due to their reduced staff. OTA also is proposing to change its name to reflect its added responsibilities. In addition, the fifth division under the current structure, the office of training support, is being renamed the division of communication media, although the division's functions will remain unchanged.

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