Chemical Characterization is an important component in the safety evaluation of medical devices. Understanding the chemical make up of the device is an important step in that evaluation. The basic premise is defining the devices chemical composition in terms of what may be released, to allow for understanding how that may impact the patient exposed to the device. This knowledge provides a better understanding of the in vivo and/or in vitro responses observed or expected. The chemical characterization does not stand alone, but goes in conjunction with the Toxicological Risk Assessment which provides the context for the chemical results. The combination of the chemistry and TRA potentially can allow for addressing biocompatibility endpoints. This presentation will provide a general overview of the goals and procedures of conducting a chemical characterization.