FDA Develops Color Additive Calculator for Device Components

As part of its Medical Device Development Tools (MDDT) initiative, the FDA has developed a screening tool to aid in evaluating the biocompatibility of polymeric medical device components that contain color additives.

The CHRIS (CHemical RISk) calculator was developed by a team led by David Saylor in the FDA’s Office of Science and Engineering Laboratories. 

The calculator looks at tolerable intake values and then predicts exposure. The FDA’s list of toxicological profiles and tolerable intake values of 11 color additives commonly used in medical devices includes titanium dioxide, carbon black, phthalocyanine green and ultramarine blue.

The calculator can also address acute systemic, reproductive, developmental, and subacute/subchronic, toxicity, as well as genotoxicity and carcinogenicity.