Color Additive Risk Evaluation Tool Qualified As New Medical Device Development Tool

A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.

• Source: Shutterstock

A color additive risk emulation tool named CHRIS (CHemical RISk calculator) has gained new Medical Device Development Tool (MDDT) designation through a voluntary program of the US Food and Drug Administration.

CHRIS is a non-clinical assessment model that helps medical device manufacturers address the biocompatibility of color additives in polymeric medical...

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