Toxicology of medical device material.

ABSTRACT

The 1976 amendments to the Food, 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.