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U.S. Department of Health and Human Services

About FDA

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FY 2000 OST Annual Report Preface

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.

OST supports the scientific basis for the Agency’s regulatory policies through the development of independent laboratory information for regulatory and other public health activities of CDRH. OST accomplishes this mission by managing, developing, and supporting standards used for regulatory assessments; performing laboratory evaluations and analyses in support of CDRH premarket and postmarket activities; developing data needed for current and future regulatory problems; and performing research, anticipating the impact of technology on the safety, effectiveness, and use of regulated products.

Specifically, OST develops and conducts research and testing programs in the areas of physical, life, and engineering sciences related to the human health effects of radiation and medical device technologies. OST develops specific scientific expertise for CDRH decision-making and analyses for health-risk assessments. The Office develops new or improved measurement methods, techniques, instruments, and analytical procedures for evaluating product performance and reliability. OST also provides innovative solutions to public health problems by developing generic techniques to enhance product safety and effectiveness. The Office prepares CDRH with the targeted science needed to ask the right questions early. 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 update our readers about OST's organization, staffing, and intramural science activities; provide a summary of our 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 fiscal year 2000. The Annual Report is an overview rather than a comprehensive accounting. For additional information, please contact us. The report might also be viewed as a source of information regarding areas in which Cooperative Research and Development Agreements (CRADAs) can be initiated with interested institutions. OST welcomes comments on the programs described in this report. We hope you find this report useful and informative, and we invite any comments you might want to offer.

  Donald E. Marlowe
Office of Science and Technology