Labelling Questions (use of color and symbols)


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I've spent a good deal of time looking but have not found anything definitive for Medical Device manufacturer selling exclusively in USA.

1) Use of color--- boxes of multiple different products looks similar (obviously the label is unique to product type, but it would be good to incorporate color to make it easier for the customer to grab the right product)... the proposal is to add an additional sticker to the side of the box i.e. if the customer knows Part 123 always has a Green sticker, they dont need to look through their whole shelf to grab it. Are there any obvious concerns with this plan? It seems the FDA would consider this part of product "labelling" but past that, I don't see much that explicitly talks about the use of color in this way

2) Are there any requirements around removing certain symbols from external label if all that information is still in the IFU (i.e. storage parameters). The FDA seems to require very little on the exterior label, though I do see what appears to be a voluntary international standard that says certain additional information "should" be on the outside label.. My understanding is that this would largely be a risk-based decision--- i.e. we may consider certain labelling symbols as risk mitigation factors, and removing them might increase certain risks, but there doesn't seem to be anything that formally says "thou must include storage parameters on outside label"

Ed Panek

QA RA Small Med Dev Company
Super Moderator
I dont think various colors is an issue unless a color blind person could cause injury to themselves or another.

FDA is primarily concerned with the "Final package label" This is the label that a user sees immediately on using the product. For a bottle of aspirin its the actual bottle, although the same information is provided on the retail packaging. Some drugs are also provided with a symbol on the actual pill for a final safety check.

For storage conditions I would place that information on the label most likely to be looked at when storing the product. A risk analysis output would also help and perhaps feedback from human factors study.
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