FDA Requirements for the Use of Symbols on Medical Device Labels

Hi,
We make medical devices (non-IVD, class 2, some 1) that sell in US as well as in EU and other international markets.FDA require that we explain all the symbols in English Text - this might create a problem when we market this in Europe as all non-english text on the label will need translation. This will end up in making the label too large for the product packaging to hold.How are you working around this issue for your products?

Any suggestions greatly appreciated.
P.

P.S. In the past, FDA was agreeable to having the explanation of symbols in the IFU (labelling). Now, the scrutiny is much stricter and they are requiring this on the label.

Re: Use of Symbols on Medical Device Labels - FDA

If the symbols are harmonized i.e in accordance with EN 980, then no translation or accompanying text is needed. Good luck

Re: Use of Symbols on Medical Device Labels - FDA

rclanzillotto said:

If the symbols are harmonized i.e in accordance with EN 980, then no translation or accompanying text is needed. Good luck

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Thanks for your response. Can you point me to a regulation/guidance doc. that says that EN 980 symbols are acceptable to FDA for non-IVD devices?

Re: Use of Symbols on Medical Device Labels - FDA

adv_webdev said:

Thanks for your response. Can you point me to a regulation/guidance doc. that says that EN 980 symbols are acceptable to FDA for non-IVD devices?

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I am not familiar with EN 980 but ISO 15223 is recognized by FDA.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm

Re: Use of Symbols on Medical Device Labels - FDA

treesei said:

I am not familiar with EN 980 but ISO 15223 is recognized by FDA.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm

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ISO 15223 does not declare any symbol as a known symbol (unlike EN 980) and exempt them from explanation in the IFU. Thanks for the link, though. I didn't know about this.

My actual question is this: Since FDA requires text explanation of symbols on labels and all of EU requires all English text to be translated in all regional languages, how can you put all the information in the small available space on a label? Do you have separate labels for US and EU or you use some other method to balance these two requirements?

P.

Re: Use of Symbols on Medical Device Labels - FDA

I would not give up on defining the symbols in the translated user guide for Europe. If this is what ISO 15223 allows you to do then it is clear. If ISO 15223 is not clear with respect to it..then your answer lies in Risk Management IMHO

Re: Use of Symbols on Medical Device Labels - FDA

FDA does require more and more often that all symbols are explained in "english wording".

To avoid any problems with your packaging for the rest of the world, one way of proceeding is to put the explanation on a separate label. This is acceptable for FDA. English wording has to be on the outside of your packaging, but there is no requirement that it should be on the same label.

You can for example have a label with the distributor (also required) and explanation of the symbols.

Re: Use of Symbols on Medical Device Labels - FDA

Dudes said:

FDA does require more and more often that all symbols are explained in "english wording".

To avoid any problems with your packaging for the rest of the world, one way of proceeding is to put the explanation on a separate label. This is acceptable for FDA. English wording has to be on the outside of your packaging, but there is no requirement that it should be on the same label.

You can for example have a label with the distributor (also required) and explanation of the symbols.

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There is one problem, though. There is no way to specify that products distributed in US will have this additinal sticker exclusively. If we apply this sticker on all product, then we need to provide translation for the English text, if it gets sold in EU. So, would you suggest having all the translations on another sticker as well?

Re: Use of Symbols on Medical Device Labels - FDA

Simbologia etichetta del prodotto

in Italian

Re: Use of Symbols on Medical Device Labels - FDA

adv_webdev said:

We make medical devices (non-IVD, class 2, some 1) that sell in US as well as in EU and other international markets.FDA require that we explain all the symbols in English Text - this might create a problem when we market this in Europe as all non-english text on the label will need translation. This will end up in making the label too large for the product packaging to hold.How are you working around this issue for your products?

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We make hundreds of products with classifications like yours, for US-and-EU sale under our name and the names of many US and European OEMs. For that latter group of customers, we are the regulatorily responsible Manufacturer and our customer is a distributor. In all such cases, we use EN 980/ISO 15223 symbology on the label, with English-only subtext for each symbol in a small but readable font size. We have been doing this for a number of years now, and have had no objection from US FDA, our NB, our Authorized Representative, authorities in Europe, or end users.