Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables

This document provides guidelines for the design of toxicokinetic studies related to degradation products and extractables from medical devices. It outlines the principles and methods for evaluating the absorption, distribution, metabolism, and excretion of these substances within the body. The scope includes the identification of relevant substances, selection of appropriate animal models, and the determination of relevant parameters for toxicokinetic evaluation. It also addresses the consideration of factors such as route of exposure, dose levels, and duration of study. The document is intended to support the assessment of potential biological risks associated with medical devices throughout their lifecycle. It serves as a reference for manufacturers, researchers, and regulatory authorities involved in the evaluation of medical device safety. The content is structured to facilitate the application of toxicokinetic data in the overall biological evaluation of medical devices.