Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices.

Abstract

Innovation in the medical device industry is challenging due to the increasing physicochemical, structural, and engineering complexity of devices; proliferation of combination products; advent of long-term implants; and variable approaches to assessing tissue reactions. Nonclinical evaluation of biological responses to implanted devices requires careful study design and implementation of pathology practices to obtain the best data for translating device-related tissue reactions ("toxicity") and