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

Abstract

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 product