Return to the Table of Contents.
The Office of Science and Technology (OST) is the laboratory of the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration. One of the various functions of the laboratories is to develop independent scientific information for regulatory and other public health activities of the Center. OST accomplishes this portion of its mission by anticipating the impact of technology on the safety, effectiveness, and use of regulated products; developing data needed for current and future regulatory problems; performing laboratory evaluations and analyses in support of CDRH premarket and postmarket activities; and managing, developing, and supporting standards used for regulatory assessments.
Specifically, OST develops and conducts laboratory and field research and testing programs in the physical, life, and engineering sciences related to the human health effects of radiation and medical device technologies, and it provides expertise and analyses for health risk assessments. The Office also develops new or improved measurement methods, techniques, instruments, and analytical procedures for evaluating product performance and reliability. OST provides innovative solutions to public health problems through the development of generic techniques to enhance product safety and effectiveness. The laboratory activities of the Office have four major focus areas: characterization of the constituents or components of products; measurement of product performance; bioeffects which derive from human exposure to radiation or medical devices; and radiation metrology in support of Agency regulation of radiation emitting products.
The purpose of the OST Annual Report is to provide information on organization, staffing, and intramural science activities; direct lab support for premarket review and compliance cases; and provide a bibliography of scientific publications, presentations, contracts, patents, and research seminars of the Office for this year. The format of the Annual Report is that of an overview rather than a comprehensive accounting. The Annual Report should also be viewed as a source of information regarding areas in which Cooperative Research and Development Agreements (CRADAs) can be initiated with interested institutions. Comments are welcome on the programs described in this report.
Donald E. Marlowe
Acting Director
Office of Science and Technology