What is CHRIS? The CHemical RISk calculators (CHRIS) are a collection of modules to facilitate the use of physics-based models to estimate exposure as part of toxicological risk assessment (TRA) of medical device polymers. There are two different categories of modules, which include Medical Device Development Tools (MDDTs) and Regulatory Science Tools (RSTs). CHemical RISk calculator (CHRIS) – Color Additives MDDT is a Nonclinical Assessment Model (NAM) to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs). These assessments can assist device manufacturers by providing instantaneous feedback on whether the presence of CAs or other additives and impurities associated with CAs in a device would require additional justification and/or testing to demonstrate acceptable biological risk. As a qualified Medical Device Development Tool (MDDT), medical device sponsors can choose to use thi...