Abstract
Medical devices and their component materials are potential sources of toxins that may produce undesirable local or systemic effects when used clinically. Federal regulations thus require manufacturers to establish the safety of their products. Until 1987, FDA provided few specific guidelines for testing medical devices, although many standardized testing methods had been placed in use by industry. Now, proposed guidelines exist, but device manufacturers still face significant problems that are similar to those encountered when testing drugs and chemicals: (1) a strategy for testing must be established to make best use of screening methods, to develop parallel information about various families of products, and to make best use of resources, (2) test articles must be selected to represent finished products, not prototype formulations, (3) sample preparation must be appropriate and relate to product use conditions, (4) test methods that are inappropriate based on end use of a product must be avoided, (5) all potential sources of toxins must be taken into account, including raw materials, processing and manufacturing aids, and sterilization processes, and (6) Good Laboratory Practices must receive appropriate attention. In vitro alternatives to animal test methods are used widely for primary evaluation of biocompatibility, but suitable animal models are not yet available for preclinical evaluation of some devices.