FY 2009 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 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.
OSEL scientists conducted cutting edge research in 2009 that continues to directly impact the public health. For example, scientists have been investigating the use of semantic analysis to automatically analyze textual data contained in various regulatory documents. Semantic analysis is a novel data mining approach that provides the theory and methods for extracting and representing contextual-usage meaning of words by statistical computations applied to a large corpus of text. (For more, see section on Office of Science and Engineering Laboratories 2009 Highlights.)
OSEL also spearheads the research in the booming field of nanotechnology, defined as “the science of manipulating materials on an atomic or molecular scale especially to build microscopic devices.” Researchers have been studying and continue to learn more about the potential biological effects and critical properties of nanomaterials in medical devices. One example is research on the antimicrobial property of silver nanoparticles. Nanoparticulate silver systems are being used increasingly as antimicrobial agents in medical devices such as wound dressings and implant coatings. OSEL scientists have been investigating the degree to which the local biological environment might interact with silver in the nanoparticle, which can affect the behavior of the device in use. Results of the on-going studies were presented at professional society conferences and published in scientific journals.
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.
We hope you find this document useful and informative. We welcome your comments on the programs described in this report.
Steven K. Pollack, Ph.D.
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.