ABSTRACT
A primary screen of the consequences of the immune response to materials and medical devices are often discernible by nonclinical histopathology evaluation of the lymphoid tissue. Toxicologic pathologists are ideally suited to provide high-level safety assessment for biocompatibility and risk, efficacy in animal models, and to act as an important member of device development teams involving biomaterial and academic scientists, bioengineers, and the medical profession. A Premarket approval is similar to a New Drug Application for drugs in that it grants marketing approval for a novel medical device, by requiring scientific evidence of safety and efficacy through preclinical and clinical studies. The International Organization for Standardization refers to biocompatibility, safety, and efficacy testing standards under the category of biological evaluation of medical devices. As acute or chronic preclinical animal safety tests are generally reviewed and discussed separately from in vivo biocompatibility tests, a terminology distinction is made between in vivo biocompatibility and the in vivo safety animal testing.
