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OCD FY2003: Letter from the Director

I’m pleased to issue the annual report for FDA’s Center for Devices and Radiological Health covering Fiscal Year 2003. In a sense, I’m doing this “by proxy,” since I hadn’t yet been appointed Center director in FY 03. I’m also issuing the report a bit belatedly—as I’m sure you’ve noted, FY 03 came to a close eight months ago! Nonetheless, I’m very proud of what the staff was able to accomplish during that year in fulfilling the Center’s major goals, and I thought it was important to share their successes with you. Let me mention just a few highlights. You’ll find the rest of the information in the remainder of this document.

We had two major objectives in FY 03: to implement the provisions of the Medical Device User Fee and Modernization Act (MDUFMA), and to carry out the goals we set for ourselves under the Center’s strategic plan.

Under MDUFMA, I’m pleased to say that we managed to meet all the statutory start-up dates for FY 03. The provisions of this law are complex and far-ranging, and so we made every effort to give stakeholders the opportunity to provide their views on implementation, including establishing Internet sites to gather feedback and conducting a nationwide interactive video teleconference.

A key element in our ability to successfully implement MDUFMA is strengthening the expertise of our staff. We made significant headway in that area during FY 03 by filling 75 new positions, including scientists, engineers, project managers, statisticians and medical officers. And to help existing staff, we launched a joint project with Georgetown University and Virginia Tech, in which our people received graduate-level training in such areas as biostatistics and product development.

In response to the MDUFMA requirement that pediatric expertise be represented on our advisory panels when appropriate, we developed guidance on the circumstances under which pediatric input should be used, as well as guidance on the premarket evaluation of pediatric medical devices.

A major accomplishment in fulfilling the goals of our Strategic Plan was the establishment of the Office of In Vitro Diagnostic Device Evaluation and Safety, a multidisciplinary group organized to regulate these products in both their premarket and postmarket phases.


We continued to strengthen our MedSun system, a pilot program through which medical facilities across the country are recruited and trained to report device-related adverse events; at the close of FY 03, 180 facilities were participating. And we continued to work towards the accreditation of third parties to perform inspections; at the close of FY 03, seventeen applications were under full review.

I should also mention that we made significant progress in improving the expertise and efficiency of our own staff. For example, we implemented a Scorecard system to better manage, measure and track our own performance, and we’re using “shared hires,” a flexible system that enables staff members to apply their skills across the entire Center. We also established a Medical Device Fellowship Program, in which outside experts bring their special skills to the Center for varying periods of time, and in which our staff members expand their knowledge by working with universities and hospitals.

Aside from personnel improvements, we’re also concerned about improving the way we operate across the board, and so we established a Continuous Process Improvement program, in which we analyze and attempt to improve the processes that we routinely use in regulating devices. Among the processes subjected to this analysis during FY 03 were PMA filing and closeout, Turbo-510(k) inspections, BIMO procedures and risk-based inspections. During FY 03 we also prepared for our eventual move to FDA’s new White Oak, with the expectation that about 50 lab employees would move in FY 04. Finally, we contributed to FDA’s ongoing effort to enhance emergency preparedness by identifying medical devices most likely to be needed in the event of a terrorist attack, establishing a manufacturer database for these products, and setting up 24-hour emergency contacts with major U.S, medical supply firms. In addition, we finished revising the emergency response plan for radiological or nuclear emergencies. Again, there’s much more in the full report. I hope you find it useful and informative.

  Daniel G. Schultz. M.D.
Director, Center for Devices and Radiological Health