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# Device Color Additive Risk Calculator Qualified
- URL: https://www.fdaweb.com/device-color-additive-risk-calculator-qualified/
- Published: 2022-11-28T12:00:00.000Z
- Updated: 2026-09-14T18:07:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153271

CDRH has qualified the “CHemical RISk calculator (CHRIS) — Color Additives” under its Medical Device Development Tools program. The CHRIS tool is described as a non-clinical assessment model that can be used by device firms to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs). It is designed to calculate a “conservative margin of safety value for a CA contained within a polymeric medical device component to aid in determining if further assessment of one or more biocompatibility endpoints is necessary for the CA and/or associated impurities based on the input provided by the user,” a [CDRH notice ](https://www.fda.gov/media/163472/download?ref=fdaweb.com)says.