Pathology and Histopathology Evaluations of Biomaterials and Medical Devices

This chapter will focus on pathology- and histopathology-based study interactions that will optimize the study design, tissue collection and preparation, and evaluation, interpretation, and documentation of biologic responses to biomaterials and finished medical devices. Much of provided information is also applicable to pathology and histopathology evaluations of combination products (device and pharmaceutical or biologics) and regenerative medicine products that include engineered or polymer scaffolds. The reader should be familiar with and consult the most recent ISO and country-specific regulatory standards and reviews to ensure regulatory compliance with the pathology components of any study.