Re: Final rule on use of symbols on labeling - Symbols without text under some condit
Hello, I am in need of clarification or guidance on the FDA's ruling.
I understand we can use standardized symbols that are contained in the approved list of standards without additional text providing we have Glossary of the used symbols in the IFU (for example) and we reference what standard the symbol is in, am I correct so far?
What I am confused about is if we use a symbol that isn't in a standard, one that we developed, if we validated that symbol using 15223-2, can we continue to use that symbol in labels, without text, if we also reference it the Glossary of symbols in our IFU? If this is allowed, what if we also included the appropriate symbol to indicate "consult instructions for use" with our validated symbols?
My example is, we have a product that is battery operated and has indicator lights that alert the user that the battery ok, or the battery is low, there is another indicator light to alert the user there is a problem (either dead battery, or other malfunction). Located on the device is a tag, the tag has a "green check mark", this green check mark looks the same as one of the indicator lights on the device (the indicator light is a green check mark), on the tag the green check mark is followed by the word "OK", another symbol the tag has is "green check mark with lines around it symbolizing a flashing light" next to that symbol is an equal sign and a depiction of a low battery" this is to indicate the device is ok to use, but beware it has a low battery. The tag also has a "red X", one of the indicator lights on the device is a "red X", next to the red X is the blue man symbol used in 60601 to consult the IFU/service manual. The tag was validated and shown that the symbols were easy to understand by the user. We have included the symbols in our glossary of symbols located in the Service Manual.
I'm wondering if the tag qualifies as a label (I figured it was, but I was just checking), and if the "Green check mark" and "Red X" qualify as symbols since they are a replica of the indicator lights that are used on the device, and since we validated the tag can we continue to use the symbols on it as stand alone symbols. TIA