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U.S. Department of Health and Human Services

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FY 2005 OSEL Annual Report Preface

The mission of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.

The Office of Science and Engineering Laboratories (OSEL), one of seven Offices within the Center for Devices and Radiological Health (CDRH), contributes to accomplishing the Center’s mission. OSEL serves as the laboratory science nucleus for the Center. Specifically, OSEL supports the scientific basis for the Agency’s regulatory decision- making by developing independent laboratory information for regulatory and other public health activities of CDRH. In addition to providing consultation to the Center’s regulatory experts, OSEL researchers are involved in mission-oriented science activities including test methods development, risk assessments, forensic investigations, product evaluations, and technology forecasting.

From a science standpoint, OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences as related to the human health effects of medical devices. CDRH relies upon this work to support its efforts ensuring public safety in areas as varied as accredited mammography facilities, breast implants, or drug eluting stents.

Since mid-2003, the Office has undergone at least three major transformations which have helped shape a strong organization. The first was the move of the newly reorganized Division of Biology to the newly constructed FDA Life Science Laboratories in White Oak, Maryland. This move was the beginning of a planned consolidation of FDA facilities. The remaining OSEL divisions are expected to move to the White Oak facilities in 2007. The second change involves what has been termed the science prioritization process. In the beginning of 2004, the Office instituted an ongoing process of conducting reviews of all OSEL research programs. This process is continuing to evolve and has made significant changes in the way research is proposed and how its value to the Center is evaluated. The third major change is the reorganization itself. OSEL was formally reorganized in early 2004 to improve the overall operating efficiency of the Office and to better integrate it into the mission and functions of CDRH. The reorganization created a new structure in which six new divisions replaced four former divisions in the Office and effectively removed all designated branches.

This reorganization has taken place at a crucial time. Over the past few years, with MDUFMA (Medical Device User Fee and Modernization Act of 2002) legislation and accompanying resources, the Office has been broadening and improving its scientific program. This provides OSEL management an excellent opportunity to increase collaboration with other components of CDRH. Finally, with the recent move of the life sciences staff to White Oak and the impending construction of the engineering and physics building, the prospects for OSEL are promising.

OSEL long-term goals focus on the following:

  • Chart a course to becoming an exciting and dynamic organization for cutting-edge regulatory research in medical devices.
  • Integrate the structure and work of OSEL with the mission and function of CDRH.

The OSEL Annual Report provides current information about the Office’s organization and intramural science activities; provides a summary of the Office’s direct laboratory support for pre-market review and post-market evaluation; and provides a bibliography of scientific publications, presentations, and research seminars for the fiscal year. The report is presented along the line of OSEL organization structure where the divisions are described first, followed by descriptions of the research laboratories. The laboratory descriptions contain abstracts of research projects as well as their accomplishments. This report also summarizes the regulatory support work that OSEL provides to the Center’s post-and pre-market offices.

OSEL management welcomes comments on the programs described in this report. We hope you find this document useful and informative, and your comments are welcome.

For additional information, please visit the OSEL web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115989.htm or contact us at 301.827.4777.

Larry G. Kessler, Sc.D.
Director
Office of Science and Engineering Laboratories