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OCD FY2006: Message from the Center Director

Center for Devices and Radiological Health

CDRH FY 2006 Highlights
October 1, 2005–September 30, 2006

U.S. Food and Drug Administration U.S. Department of Health and Human Services

Mission/Vision

Mission
CDRH protects the health of the public by assuring the safety and effectiveness of medical devices and the safety of radiological products marketed in the United States. To further safeguard public health, CDRH monitors medical devices and radiological products while in use for continued safety and disseminates accurate, science-based information about the regulated products.

Vision
To protect the health of the public by assuring the safety of medical devices and radiological products throughout the Total Product Life Cycle - from product conception and development, through production and use, to obsolescence and product replacement.

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Message from the Center Director

Fiscal year 2006 coincided with the 100 th Anniversary of the FDA, the oldest consumer protection agency in the nation. As one of five FDA centers, the Center for Devices and Radiological Health (CDRH) plays an integral role in efforts to safeguard the public health. It is therefore fitting to align CDRH fiscal year 2006 accomplishments with four overarching Agency goals:

  • To empower patients and consumers and enhance public health through better information about regulated products;
  • To increase access to innovative products and technologies to improve health;
  • To improve product quality, safety, and availability through better manufacturing and product oversight; and
  • To transform FDA business operations, systems, and infrastructure to support FDA’s mission in the 21 st century.

As an introduction to the Center’s Fiscal Year (FY) 2006 Annual Report, I would like to highlight select accomplishments under each of the four goals. I highlight these accomplishments on behalf of and in recognition of the many individuals - staff and stakeholders - who contributed to the successful work of CDRH during the fiscal year.

 To empower patients and consumers and enhance public health through better information about regulated products 

The CDRH website increasingly serves as the source of information about regulated products for consumers, clinicians, and industry. An important addition to the website this fiscal year was the RightNow Inquiry Management System. The system provides ready answers to consumers frequently asked questions and integrates questions posed online.

CDRH outreach staff also consolidated and organized medical device safety information on a single page of the CDRH website to afford healthcare professionals easy access to the information.

The Annual Report contains detail on numerous activities (courses, workshops, conferences, etc.) that CDRH co-sponsored with industry. These activities testify to the Center’s ongoing commitment to provide information and regulatory assistance to device manufacturers.

 To increase access to innovative products and technologies to improve health 

I am pleased to report that CDRH continues to make steady progress in meeting MDUFMA performance goals. The Center has met or is on track to meet most goals for FYs 2003–2006. During this FY, CDRH issued 6 MDUFMA guidance documents; held 2 MDUFMA stakeholders meetings; issued 14 Federal Register notices and 3 reports to Congress; and granted 698 Small Business Determinations - an 8 percent increase over FY 2005.

CDRH applied research is a springboard for development of new device technologies. Among the Center’s research-related strengths is the availability of scientists with cutting-edge expertise in a range of fields. This is evident, for example, in multi-disciplinary efforts in FY 2006 to assure readiness to address future nanotechnology products and issues.

Each year one of the most rewarding aspects of developing the annual report is listing approved/cleared devices that have a direct impact on patient care. CDRH was pleased to grant a Clinical Laboratory Improvement Amendment (CLIA) waiver for a simple and accurate rapid blood lead test system. The waiver broadened access to the test to more than 115,000 point-of-care locations nationwide. Devices approved during FY 2006 included a continuous glucose monitoring system that detects blood glucose trends and tracks patterns for diabetic patients and a device that provides an alternative to open heart surgery for pediatric and young adult patients.

 To improve product quality, safety, and availability through better manufacturing and product oversight 

The Center continues to enhance postmarket oversight to ensure the safety and effectiveness of products. During FY 2006, CDRH received over 200,000 adverse event reports concerning medical devices, classified 651 recall actions involving 1,550 products, and took at least 55 enforcement actions. CDRH exceeded FY 2006 inspection goals by at least 20 percent for domestic, foreign, and bioresearch monitoring (BIMO) inspections. The Center also conducted annual inspections at over 8,000 mammography facilities, ensuring that 98 percent met inspection standards with less that 2 percent of the facilities having Level I (serious) problems.

 To transform FDA business operations, systems, and infrastructure to support FDA’s mission in the 21 st century 

As part of an ongoing effort to improve the postmarket tools we employ to monitor nearly 100,000 medical products, the Center produced a comprehensive report on the Postmarket Device Safety Program. The report highlighted implementation challenges and recommended action steps to strengthen the program. A senior level Postmarket Transformation Leadership Team met throughout FY 2006 to evaluate the recommendations and propose a plan for a transformed postmarket program.

During the fiscal year, CDRH enhanced Center IT systems to facilitate submissions, expedite reviews, and simplify tracking of devices throughout the product life cycle.

The availability of excellent staff is paramount to the Center’s success and attention to training through the new employee orientation program, and the competency development program was another hallmark of FY 2006.

Spurred by our successes and cognizant of the challenges inherent in an ever expanding market for medical devices and radiological products, CDRH staff is committed to continuing the work outlined in this Annual Report. We hope that you will read the report with interest and that it will reinforce your trust in our ability to ensure the safety and effectiveness of the medical products you depend upon.

Daniel G. Schultz, M.D.
Director