FY 2004 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), formerly the Office of Science and Technology (OST), is one of seven Offices within the Center for Devices and Radiological Health (CDRH). The seven CDRH Offices are comprised of six program offices (of which OSEL is one) and one administrative and technological support office. 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 changes that have helped shape the new organization, the Office of Science and Engineering Laboratories (OSEL). 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 concerns the science prioritization process. In the beginning of 2004, the Office conducted a review of all 14 programs in an ongoing process to bring advice from the rest of CDRH and FDA to assist in developing the direction for the lab programs. The third and final major change is the reorganization itself. OST 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. This reorganization is expected to clarify the ongoing research within the Office for both FDA and outside scientists. The reorganization has created a new structure in which six new divisions have replaced the four former divisions in OST and has removed all designated branches. The new office is named the Office of Science and Engineering Laboratories (OSEL).
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 had an opportunity to broaden and improve its scientific program. This gives the management an excellent incentive to increase the 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 compliance cases; and provides a bibliography of scientific publications, presentations, and research seminars for the fiscal year. OSEL management welcomes comments on the programs described in this report. We hope you find this report useful and informative, and your comments are welcome.
For additional information, please contact us at 301.827.4777.
Larry G. Kessler, Sc.D.
Office of Science and Engineering Laboratories
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 Food and Drug Administration or the Department of Health and Human Services.