Final rule on use of symbols on labeling - Symbols without text under some conditions

[funkgirl]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

I just don't get the text pointer to the IFU specifying the location of the glossary, when there are 2 symbols in 15223-1 that do the same thing. I feel that it's totally misleading of FDA to say that the standard is recognized in full when they add this ridiculous requirement that adds text that will require translation, thus defeating the benefit of using symbols. Someone please tell me I'm missing something

 

[Ronen E]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

I just don't get the text pointer to the IFU specifying the location of the glossary, when there are 2 symbols in 15223-1 that do the same thing. I feel that it's totally misleading of FDA to say that the standard is recognized in full when they add this ridiculous requirement that adds text that will require translation, thus defeating the benefit of using symbols. Someone please tell me I'm missing something

Not sure that the text pointer to the symbols glossary will require translation.

...the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary...

(801.15)

You could add a separate insert conspicuously showing the above (and nothing else) to the US version of the device, while eliminating it from all other markets' versions. Granted, it's an added burden but at least it will save translation wherever you were able to reduce labelling to symbols only. That's the best I can currently think of.

 

[funkgirl]

Re: Final rule on use of symbols on labeling - Symbols without text under some condit

Thanks for your response! I think this is one of those things that will stick in my craw until it's changed. Hopefully, I'll get over it soon

 

[Cyprusbirthdaycake]

Hi all,

Just a question. Our device basically produces analysis reports on a patient's heart health. Can text on the software interface replace a required symbol as prescribed by the updated 15223 standard? We don't want to be repeating the same information through a symbol and corresponding text so we would like to just use text to represent certain key details e.g product is a medical device, the actual UDI details. Is this allowed as long we rationalise in our transition plan that we are doing this?

Thanks.

Arimita