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Chemical RISk (CHRIS) Calculator is Qualified as a New Medical Device Development Tool
 The U.S. Food and Drug Administration (FDA) qualified the “CHemical RISk calculator (CHRIS)- Color Additives” through the voluntary Medical Device Development Tools (MDDT) program.
The MDDT-qualified CHRIS – Color Additives tool:
- Is a non-clinical assessment model (NAM) that can be used by medical device companies and sponsor-investigators to conduct screening level risk assessments to aid in the biocompatibility evaluation of polymeric medical device components that contain color additives (CAs).
- Calculates 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. As with other MDDTs, all assessments are dependent on the tool being used within its Context of Use.
- 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.
CHRIS – Color Additives is published as an online tool available at Medical Device Development Tool
Questions?
If you have questions about the MDDT Program, contact MDDT@fda.hhs.gov
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