FY 2007 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 CDRH, contributes to the Center’s mission by providing laboratory data and consults. 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 assessment.
From a science standpoint, OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences as related to the effects of medical devices on human health. 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.
OSEL long-term goals:
- 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.
OSEL completed the geographic consolidation of its six laboratory-based divisions (as part of the FDA campus consolidation) to Silver Spring, Maryland, in early 2007. Additionally, OSEL management concluded the Science Prioritization Process (SPP) in 2007. The SSP was created and designed to identify, evaluate, and prioritize existing and/or proposed research projects. The projects must directly address the high-priority review and regulatory needs of the Center and Agency.
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.
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health, FDA
and Chair, Global Harmonization Task Force