FDA Medical Device Pigments
Foster Corporation offers both custom pre-colored compounds and stock universal color concentrates, manufactured using medical device pigments, certified to FDA 21 CFR 73 Subpart D.
What is FDA 21 CFR 73 Subpart D?
The Food, Drug and Cosmetic (FD&C) Act, initiated by the FDA limits the use of non-certified color additives in medical devices and surgical tools that may be in contact with the human body for an extended period of time. Pigments listed under Title 21 of the Code of Federal Regulations (CFR) Parts 73 & 74, Subpart D are certified by the FDA as safe for use in such devices. Unlike those listed under 21 CFR 74, Part 73 pigments are exempt from batch certification. Please note however, that finished medical device manufacturers are still required to complete FDA submission and any associated testing on the final device.
For more information, please visit www.fda.gov