adv_webdev
Starting to get Involved
Re: Use of Symbols on Medical Device Labels - FDA
Thank you, this is good to know.
P.
Thank you, this is good to know.
P.
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.
Does your distributes sell all over Europe?
Did you have to take any discussions with the Regulatory Authorities of any of the EU countries regarding the labeling?
Are you using only symbols from these standards or do you also have designed own symbols?
Hi adv_webdevISO 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.
Scope
This part of ISO 15223 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of ISO 15223.
...all of EU requires all English text to be translated in all regional languages...
But where is the FDA requirement to have text coming from?My employer's understanding based on many years experience is that in practice, European authorities (and knowledgeable quasi-authorities such as notified bodies and authorized representatives) first look for a standardized symbol that communicates a particular information-element. If such a symbol is present, then English text below and accompanying that symbol and in a font substantially smaller than the symbol is tolerated, because of the regulatory understanding that US FDA has not yet harmonized regarding label symbols.
This is purely de facto. I know of no written statement of such a practice. But, we see it in effect in the marketplace every day.
But where is the FDA requirement to have text coming from? 21 CFR 801.15.c1 perhaps?
If they recognise ISO15223 which they do, both parts
Yes.
Two comments:
1. The "recognition" process is at the guidance level. 21 CFR 801.15.c1 is law. In a conflict instance, the law always governs.
2. The use of symbols is recognized only for 25 specific symbols, and only for the limited case of professional-use IVDs. For all other device types and markets, symbols are not recognized. See guidance "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended For Professional Use".
Unfortunately, FDA now is much more strict to the symbol use.
We used to print the symbol and the English explanation of the symbol on the label, and it is accepted by FDA reviewer, however, in our recent submission, FDA reviewer request us to delete the symbol, even there is explanation of the symbol on the label. I am just discussing with them and don't know the result.