Toxicological Risk Assessment Of Medical Devices: An Overview

The risk management process of medical devices used in toxicology is based on the principle for establishing allowable limits for leachable substances. The FDA required toxicological risk assessments performed for most medical device submissions founded on the notion that if all of the constituents of a medical device are known, then the safety of the device can be assessed based on the toxicology of those constituents. This white paper provides an overview of the steps to perform toxicological risk assessments. Download the full paper for more information.