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© 1989 Oxford University Press

research-article

Introduction to the Symposium Presented at the 1988 Annual Meeting of The society of Toxicology

PETER L. GOERING1 and W. DON GALLOWAY

Division of Life Sciences, Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Adminrstration Rockville, Maryland 20857

Received January 9, 1989; accepted January 17, 1989

The 1976 amendments to the Faxi, Drug, and Cosmetic Act established requirements for obtaining approval to market new medical devices, including the necessity for demonstrating safety and effectiveness. Evaluation of the potential toxicity of medical devices presents toxicologists with unique problems related to route of exposure, estimation of exposure dose, exposure to by-products generated during manufacture, and matrix effects. A symposium was organized to address the need for toxicologists to examine the potential toxicities of medical device materials, to appreciate the unique problems associated with medical device safety evaluation, to present novel testing methodologies, and to discuss future research needs.


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