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U.S. Department of Health and Human Services

About FDA

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The Division of Biology (DB) participates in the Center's mission to conduct research, participate in device review activities, develop consensus standards both domestic and international, develop regulatory guidance, test forensic and regulatory samples, and provide educational programs in the area of biological sciences. Specifically, DB conducts research to support the Center’s mission to assure the safety and effectiveness and promote the improvement of medical devices in the areas of biological risk assessment, biosensors/nanotechnology, genomic and genetic technologies, infection control and sterility, tissue-device interactions, toxicity/biocompatibility, and radiation bioeffects. Through laboratory studies, researchers evaluate the potential adverse effects of medical devices on host biological systems and, in collaboration with engineering divisions, identify the source and impact of product degradation on organ systems both under acute and chronic conditions. The Division staff develops measurements methods and analytical procedures to characterize and evaluate devices and products, studies molecular and cellular mechanisms and bioeffects of biomaterials, and supports the Center’s enforcement and product testing activities.

The DB staff members are primarily biologists, chemists, and biomaterials scientists.