Legal requirements for the preclinical toxicological evaluation of biomaterials.

Biomaterials intended for use in humans must, by law, be tested preclinically before the products can be placed on the market. Such preclinical studies should be guided by the recommendations for testing proprietary medical products. The biomaterial employed should in most cases be tested or evaluated at three levels: (1) toxicity tests with the various ingredients used to manufacture the basic biomaterial; (2) toxicity tests with the final biomaterial; and (3) toxicity tests with the final device. This article discusses the legal requirements and preclinical studies for biomaterials, suggesting that the type of test conducted, its design, and the extent of testing should depend upon the risks associated with that biomaterial.