Biomedical Engineering Program between Rutgers University and the University of Medicine and Dentistry of New Jersey entitled "Biopolymers" and "Patho biology" during the past 15 years. It is our hope that this book will provide the reader with all the infor mation necessary to understand the complexity of the biological reactions that are set into motion by implantation of a material or a device. We hope that this book will provide a framework for thinking about implant interactions with bio logical systems. Although the field of studying pathobiological responses to im plants is still in...

are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval....