2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: "Medical Device Safety Assessment:...

Medical devices represent a complex category of medicinal products with varying definitions depending on the regional jurisdiction of regulatory agencies. A common aspect of these definitions is that a medical device is intended to be used for specific medicinal purpose where the primary intended action of the device is not achieved through pharmacologic (or other chemical) means. While regional regulatory frameworks for medical devices are different than for pharmaceutical or biological products, medical device manufacturers are required to evaluate the safety and performance of these products in the context of their intended use. In biological safety evaluation, histopathology plays a relevant role in assessing medical device biocompatibility. This manuscript provides a broad overview of biocompatibility assessment with a deeper look at the role of the toxicologic pathologist in assessing innovative and emerging bone therapies. The content of this manuscript is based on individual presentations delivered at the 2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium held in conjunction with the Annual Congress of the European Society of Toxicologic Pathology (ESTP) on 26 September, in Basel, Switzerland.