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FDA Requirements for the Use of Symbols on Medical Device Labels

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A

A.I.C

#12
#12
Re: Use of Symbols on Medical Device Labels - FDA

MIREGMGR said:
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.
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Very interesting info, I would also like to use this method on our product but have been warned to do so since the older EU member countries (e.g. France and Germany) might object if there is only English subtext, even though it is combined with symbols from SS-EN 980/ ISO 15223. So this makes me wonder if:

  • 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?
The GHTF guidance doc states that:
“Provided that safe and correct use of the device is ensured, a RA may authorize labeling to be in one or more language(s) than other than its national language(s)” (attachment page 8) So obviously there is some support to use only English subtext, the question is how strict the different RA in Europe are?
 

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M

MIREGMGR

#13
#13
Re: Use of Symbols on Medical Device Labels - FDA

A.I.C said:
Does your distributes sell all over Europe?
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Distributors selling the product under our name do cover most of the EU/EEC countries, but possibly not all of them.

The regional affiliates of the multinational OEMs that distribute private-labeled versions of our products do distribute in all such countries.

Did you have to take any discussions with the Regulatory Authorities of any of the EU countries regarding the labeling?
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We've had no such direct discussions. Our only interaction other than with our distributors and end users has been with our NB and our Authorized Representative. As a company located outside the EU, all interactions with the national Regulatory Authorities are handled by our Authorized Representative. We have reason to believe that our Authorized Representative is very rigorous about compliance with the various rules and guidances. We haven't directed them to have any such discussions, and they haven't informed us of having had any such discussions.

Are you using only symbols from these standards or do you also have designed own symbols?
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Mostly the former, but some labels have one or two non-standardized information-only (i.e. non-warning, not necessary for safe and effective product use) symbols as well.
 
B

Bonebuilder

Starting to get Involved
#14
#14
Re: Use of Symbols on Medical Device Labels - FDA

adv_webdev said:
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.
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Hi adv_webdev

Is your first statement correct?

The scope of 15223-1 seems otherwise, quote;

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.
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Last edited by a moderator:
M

MIREGMGR

#15
#15
Re: Use of Symbols on Medical Device Labels - FDA

...all of EU requires all English text to be translated in all regional languages...
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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.
 
B

Bonebuilder

Starting to get Involved
#16
#16
Re: Use of Symbols on Medical Device Labels - FDA

MIREGMGR said:
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.
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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, Recognition Numbers 5-59 & 5-61 for part 1 and 5-56 for part 2

Which has precedent?
 
M

MIREGMGR

#17
#17
Re: Use of Symbols on Medical Device Labels - FDA

Bonebuilder said:
But where is the FDA requirement to have text coming from? 21 CFR 801.15.c1 perhaps?
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Yes.

If they recognise ISO15223 which they do, both parts
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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".
 
S

skime

#18
#18
Re: Use of Symbols on Medical Device Labels - FDA

We have similar question regarding symbols, the "do not use if package is damaged". ISO 15223-1:2012 calls out "In Europe, this symbol shall be expalained in the information supplied by the manufactruer" The FDA does not appear to recognze this symbol. We have limited space availble on the product and we do not use IFU's. We are exploring the option of English "Do not use if packaged is damaged" adjacent to the symbol, recongizing the absence of other languages due to space constraints. The label will be marketed US and EU. Comments?
 
W

wangyang

#19
#19
Re: Use of Symbols on Medical Device Labels - FDA

MIREGMGR said:
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".
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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. :confused:
 
B

Bonebuilder

Starting to get Involved
#20
#20
Re: Use of Symbols on Medical Device Labels - FDA

wangyang said:
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. :confused:
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Thanks for your comments

Did your reviewer give you a reason why they wouldn't allow symbols? We have similarly had devices accepted where the labels have symbols with test alongside.

Are FDA saying that labels have to be dedicated to US only? Surely that goes against the remit of "least burdensome" route to market, or am I just being naive?
 
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