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U.S. Department of Health and Human Services

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FY 2006 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), is an essential component of CDRH, providing immediate access to laboratory capabilities to assist in regulatory decision making. 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 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 joined the Division of Biology in early 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 and removed branch structure. OSEL is continuing to make significant strides in meeting these long-term goals.

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 provided OSEL management an excellent opportunity to increase collaboration with other components of CDRH. One such example is the Office of Surveillance and Biometrics and OSEL forged a collaborative research effort that provides opportunities for OSB statisticians to work alongside OSEL scientists on both defined research projects and general collaborations. Further examples include

  • OSEL has appointed senior staff members as liaisons to pre- and post-market functions of the Center. These liaisons serve as one of their primary functions in coordinating OSEL interactions in all aspects. This activity has significantly improved OSEL presence in regulatory functions of the Center.
     
  • OSEL invites specialists from industry and academia to present seminars at the Center to learn of the latest findings in device science and technology. There is a standing seminar series at the White Oak campus organized by the Division of Biology in OSEL in which highly renowned scientists are invited to speak on variety of topics of interest to the Agency.
     
  • OSEL funds research fellowships for undergraduate or doctoral students from targeted universities, such as the University of Maryland, Johns Hopkins University (JHU), and The George Washington University School of Engineering and Applied Science, who have a direct interest in medical devices. Students fill part-time or summer positions at OSEL to perform their research in OSEL laboratories. These fellowships are similar to those offered in the Center’s Medical Device Fellowship Program. The goal of these interactions has been to develop a coherent framework of interactions encompassing such activities as:
    • Collaboration in scientific investigations
    • Shared scientific expertise and facilities
    • Provision of a range of temporary and part-time CDRH positions for students and faculty
    • Joint participation in integrating FDA regulatory issues into engineering curricula
    • Joint workshops and conferences on topics of common interest, e.g., leading edge developments in medical device technologies
    • Creation of a regular venue for technical presentations by scientists from each institution

Additionally, OSEL has developed active collaborations, CRADAs, and IAGs with the National Institute on Disability and Rehabilitation Research (NIDRR), The Telemedicine and Advanced Technologies Research Center (TATRC), The National Science Foundation, National Institute of Health (NIH), National Institute of Standards and Technology (NIST).

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 research goals, description, and their accomplishments. This report also cites a few examples of 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 301.796-2530.

Larry G. Kessler, Sc.D.
Director
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health, FDA
and Chair, Global Harmonization Task Force