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U.S. Department of Health and Human Services

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OCD FY2005: Message From the Center Director

Dear Reader,

I’m pleased to issue the annual report for FDA’s Center for Devices and Radiological Health, which highlights both the challenges we faced and the goals we met during Fiscal Year 2005. This letter briefly summarizes some of the major accomplishments described in the report. I encourage you to visit CDRH’s web site at www.fda.gov/cdrh to read the full report and learn more about what we do.

FY 2005 was the first year that the majority of MDUFMA performance goals went into effect. I’m pleased to report that hard work and preparation paid off—we not only fulfilled MDUFMA requirements, but maintained device review performance in areas not covered by MDUFMA. And we’re now in the process of preparing for MDUFMA II.

Seventy percent of our resources were related to MDUFMA activities in FY2005. This involved all aspects of the review process, including condition of approval studies, statistical review, human factors review, labeling review, research and consultation, review of manufacturing practices, pre-approval inspections and third party inspections.

With MDUFMA, we are making significant strides in our premarket programs. But our responsibility to public health goes beyond premarket review. We also need to transform our postmarket program to better monitor the safety of medical devices after they reach the market. This year we took a major first step in that direction with a comprehensive, year-long internal inventory of the tools used to monitor the safety of medical devices after they are in use. The inventory identified areas where we are performing well, as well as those where we need to improve. With the inventory as a roadmap, we will take steps to enhance our ability to identify, analyze, and act on problems quickly, so that we can better alert patients and health professionals about medical device safety issues.

In order to get our medical device safety messages to the people who need them, we must have an effective communications system that will link us with clinicians, medical institutions, patients and the general public. To help satisfy that need, we began a systematic review of our medical device websites to enhance our information on product safety and to make our web pages more accessible and user-friendly. We began research to determine whether our safety messages meet the needs of patients and the healthcare community. I’m also pleased to report that “FDA Patient Safety News,” our video news show for health professionals, continues to attract new viewers, with a 40 percent increase in visitors to the show’s dedicated website in FY 2005.

Medical device technology is moving forward at incredible speed, and our internal research programs help us keep pace with emerging science. They make an important contribution to our product review process, and help stimulate the development of new evaluation tools. For example, CDRH scientists conducted research in 2005 that aided in the evaluation of a post-approval study application for a pediatric left ventricular assist device (LVAD).

In an age of rapid scientific and medical progress, it is vital that we strengthen our interactions with the academic and clinical communities. Our Medical Device Fellowship Program continues to attract outside experts to work with us on a short-term basis, sharing their expertise and gaining insight into our policies and public health mission. At the same time, the Center’s Staff College helps to assure that the knowledge and qualifications of our own staff are continually enhanced.

In FY 2005 CDRH commemorated 10 years of Mammography Quality Standards Act inspections. In that decade, MQSA inspectors have completed 93,000 inspections of mammography facilities. I’m pleased to note that the percentage of inspections without adverse observations has increased, and continues to do so. In FY 2005 we also published amendments to the mandatory medical x-ray performance standards that should significantly reduce patient radiation exposure from fluoroscopy.

We were presented with an unusual challenge in FY 2005 because of Hurricane Katrina. We responded quickly by issuing advice on the disposal of contaminated devices, the reopening of dialysis centers, and how to deal with medical devices that have been exposed to high heat and humidity and those that require refrigeration. I am especially proud of all of the volunteers in the Center who traveled to New Orleans and other hard-hit areas to help in the recovery effort.

To sum up, I’m proud of our accomplishments, but I’m also aware of the challenges that lie ahead: improving the efficiency and quality of our premarket review system, strengthening our postmarket program to provide a strong public health safety net for products already in use, focusing our research program to better address emerging regulatory issues, communicating more effectively within the Center, with healthcare professionals, patients and the medical device industry, improving our lines of communication with the academic and clinical communities, and assuring that our own staff is adequately trained to deal with the challenging new technologies on the horizon.

None of the progress outlined in this letter could have occurred without the commitment and hard work of everyone in the Center. I’m proud of them and grateful for their dedication to the public health.

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