CFR (Code of Federal Regulations) with Colorants help wanted

[BerryBerryGud]

This was an important post. I found it since I am in a situation where I am making the exact same request of my plastics suppliers! Here's why: I recently received the following question from the agency for a 510(k) for a medical device. The device is a single use, disposable, device, whose construction includes medical grade ABS and medical grade heat shrink tubing. Patient contact duration is about 5 minutes. I am curious to know if others have received this question recently? This is much more detail than I expected - especially since I submitted full biocompatibility testing results.

Based on the materials table provided, your device contains multiple colored components. Since certain colorants are toxicants (e.g. mutagens, carcinogens) that may need additional biocompatibility/toxicity evaluation and are subject to specific regulations (e.g. 21CFR73), please provide the following information:
a. Chemical name and the Chemical Abstract Service (CAS) number of each key colorant in the formulation
b. Purity level of the colorant
c. Estimated absolute amount of colorant (in weight) per device
d. Material Safety Data Sheet (MSDS) for each colorant
e. Identification of other US marketed medical devices by device name, manufacturer, submission number, where the colorants have been previously used, if known
f. Toxicity risk assessment of this colorant that is preferably based on the eluted amount of colorant from your device under intended use, instead of the absolute amount of the colorant
g. Whether the colorant is subject to specific FDA regulation (if known)
In addition to the issues above, please be aware that if the black colorant is carbon black (prepared by the “impingement” or “channel” process), this colorant has been terminated for use in foods, drugs, and cosmetics."
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[Ronen E]

In Reply to Parent Post by BerryBerryGud

This was an important post. I found it since I am in a situation where I am making the exact same request of my plastics suppliers! Here's why: I recently received the following question from the agency for a 510(k) for a medical device. The device is a single use, disposable, device, whose construction includes medical grade ABS and medical grade heat shrink tubing. Patient contact duration is about 5 minutes. I am curious to know if others have received this question recently? This is much more detail than I expected - especially since I submitted full biocompatibility testing results.

Based on the materials table provided, your device contains multiple colored components. Since certain colorants are toxicants (e.g. mutagens, carcinogens) that may need additional biocompatibility/toxicity evaluation and are subject to specific regulations (e.g. 21CFR73), please provide the following information:
a. Chemical name and the Chemical Abstract Service (CAS) number of each key colorant in the formulation
b. Purity level of the colorant
c. Estimated absolute amount of colorant (in weight) per device
d. Material Safety Data Sheet (MSDS) for each colorant
e. Identification of other US marketed medical devices by device name, manufacturer, submission number, where the colorants have been previously used, if known
f. Toxicity risk assessment of this colorant that is preferably based on the eluted amount of colorant from your device under intended use, instead of the absolute amount of the colorant
g. Whether the colorant is subject to specific FDA regulation (if known)
In addition to the issues above, please be aware that if the black colorant is carbon black (prepared by the “impingement” or “channel” process), this colorant has been terminated for use in foods, drugs, and cosmetics."
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Hello and welcome to the Cove

Well, the FDA does say that the biocompatibility testing matrix (based on 10993) is only a baseline, and additional tests may be required on a case by case basis.

In your case, I'd contact NAMSA (or equivalent; no affiliation here) and ask to talk to an expert toxicologist. Good chances that they will be experienced with the subject matter, and able to provide both general "tactic" advice and specific colorant-related / testing one.

Cheers,
Ronen.

PS Obviously you are also up for some legwork, collecting the required documentation from your suppliers.