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U.S. Department of Health and Human Services

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FY 2008 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 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 breadth 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 medical imaging, medical device software, breast implants, or drug eluting stents.

One major effort during 2008 was to assess the Science Prioritization Process (SPP). Since its inception in 2005, the SSP has undergone minor adjustments to make the process more responsive to CDRH needs. However, in 2008 a thorough evaluation was conducted by seeking input from all stakeholders (OSEL staff and management, technical review committee members in CDRH and FDA, and Science Prioritization Oversight Committee). A large number of their recommendations were adopted, and the improved process was implemented in 2008.  

A second major development in OSEL involves setting up complimentary network mechanisms within the office in order to facilitate implementation of CDRH Matrix organization. The CDRH Matrix organization was officially implemented in 2008, and OSEL is working with the organization and network leaders to better serve the Center’s total product life cycle goals.

The OSEL Annual Report offers 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: divisions are described first, followed by descriptions of the research laboratories. The laboratory sections contain descriptions of research goals and laboratory 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.

For additional information, please visit the OSEL web site or contact us at 301.796-2530.

 

Laurence Grossman, Ph.D.

Acting Director

Office of Science and Engineering Laboratories

Center for Devices and Radiological Health, FDA

 

Disclaimer: Please note that the mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.