ABSTRACT
Significant advances have been made in the development of biocompatible materials for use in parenteral devices, i.e., those devices that have contact with parenteral fluids, blood, and/or internal tissues other than the alimentary canal or other mucosa. Although the development of tests for biological compatibility of device materials has progressed during the past decade, knowledge of the availability of these tests by manufacturers and their acceptance for regulatory purposes has not kept abreast of current biological assessment capability. Any material to be used as a part or whole of a parenteral device should function as intended without bringing about short- or long-term adverse effects. Neither the material itself nor any leachable constituents should cause adverse local or systemic responses. As a result of the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic (FD&C) Act, most device manufacturers are aware that adequate Biological tests and studies should be undertaken to demonstrate the suitability of any materials used in the manufacture of parenteral devices.
