Re: Color Additives For Medical Devices
If you use a "direct food contact ink" for printing on a medical device (...)
Food qualifications do not necessarily establish medical safety, because qualification is specific to the application material. So, a colorant may be approved only for food contact plastic resins, and your application having no relevance to food contact and involving different colored materials wouldn't be affected by that approval. My experience is that it's best to regard the food safety and medical device safety systems for approval of colorants to be independent.
Note that in the guidance linked by Ronen above, ISO 10993 is not the direct focus; but that is the standard that you must utilize to establish medical device biocompatibility.
(...) for the
510K submission are we required to list the color additive in the ink?
The device's intended use will mean the printed area of the device will touch human skin for a short period (<24hrs). Therefore, Biocompatability testing will be performed on the finished product.
I don't know that there's a hard and fast answer on this. Given that there will be whole product testing, different examiners might see it differently. Certainly the conservative answer is that you must either report the color additive and present biocompatibility evidence for that additive and/or for the ink itself with that additive, or show in the finished-product testing that the testing process has enough sensitivity that it can detect the biocompatibility of the ink, even though the ink area within the test sample might be quite small.
This is a classic technical weakness of whole-product biocompatibility testing: that constituent patient-contact materials might be non-biocompatible, and might have significant contact but over just a small area, such that the biocompatibility testing of a multiple-material sample that is mostly other materials might not have enough sensitivity to detect the behavior of the non-biocompatible material. That's why makers sometimes test individual materials, instead of the finished product.