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FDA Requirements for the Use of Symbols on Medical Device Labels

M

MIREGMGR

#21
#21
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Inconsistency sometimes occurs in FDA reviews.

I don't know of any documented basis for FDA to request removal of symbol content from labeling if that symbol content is closely coupled to English text content that communicates the same message.

FDA has according semi-recognized status to past GHTF guidances, and GHTF/SG1/N70:2011 allows (and recommends) the use of symbols by themselves, without a need for explanatory English subtext, as long as the symbol's meaning is clear to the intended user. This of course conflicts with existing FDA guidances, but certainly would seem to oppose a reviewer going beyond the text of those existing FDA guidances in the opposite direction.

I don't interpret any of the primary FDA guidances on labeling to prohibit presence of content in addition to the required content, as long as that extra content does not mislead the intended user. In past instances of which I'm aware, symbols with fully explanatory English subtext of sufficiently prominent and readable typesize to explain the symbol meaning have not been considered misleading to the intended user.

If your reviewer is stubborn on this, you could consider appealing that point to the next review level. FDA in the past has been willing to cooperate when a device is to be label for global sales, involving conformance to multiple regulatory authority requirements, when the Manufacturer can show a reasonable effort to support safety and effectiveness via their labeling approach.
 
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W

wangyang

#22
#22
Re: Use of Symbols on Medical Device Labels - FDA

Bonebuilder said:
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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I agree with you and i try to discuss with them
 
W

wangyang

#23
#23
Re: Use of Symbols on Medical Device Labels - FDA Requirements

MIREGMGR said:
Inconsistency sometimes occurs in FDA reviews.

I don't know of any documented basis for FDA to request removal of symbol content from labeling if that symbol content is closely coupled to English text content that communicates the same message.

FDA has according semi-recognized status to past GHTF guidances, and GHTF/SG1/N70:2011 allows (and recommends) the use of symbols by themselves, without a need for explanatory English subtext, as long as the symbol's meaning is clear to the intended user. This of course conflicts with existing FDA guidances, but certainly would seem to oppose a reviewer going beyond the text of those existing FDA guidances in the opposite direction.

I don't interpret any of the primary FDA guidances on labeling to prohibit presence of content in addition to the required content, as long as that extra content does not mislead the intended user. In past instances of which I'm aware, symbols with fully explanatory English subtext of sufficiently prominent and readable typesize to explain the symbol meaning have not been considered misleading to the intended user.

If your reviewer is stubborn on this, you could consider appealing that point to the next review level. FDA in the past has been willing to cooperate when a device is to be label for global sales, involving conformance to multiple regulatory authority requirements, when the Manufacturer can show a reasonable effort to support safety and effectiveness via their labeling approach.
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Thank you for your help. I have never think of appealing to the lead reviwer. Does it work?
 
B

Bonebuilder

Starting to get Involved
#24
#24
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Yes absolutely. A reviewers role is to administer the regulations, not to interpret them.
 
S

skime

#25
#25
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Thank you for the replies.

We have encountered contradictory FDA interpretation of label symbols as well. In a 510k application the reviewer did not recognize any symbols.

When confronted with the FDA site that calls out recognized symbols the reviewed claimed that the 510k reviewer section did not recognize symbols.

Needless to say this makes life difficult to meet two opposing standards!!!
 
M

MIREGMGR

#26
#26
Re: Use of Symbols on Medical Device Labels - FDA Requirements

skime said:
In a 510k application the reviewer did not recognize any symbols.
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Per current guidance, in general symbols are not accepted by themselves (i.e. without English-language subtext), except for certain professional-use IVDs.

The acceptance is of the presence of symbols (i.e. not objecting to their being on the labeling), but not their utilization as communication elements; that communication instead being provided by English-language subtext that closely accompanies each such symbol.
 
M

mscottf

Scott Fine
#27
#27
Re: Use of Symbols on Medical Device Labels - FDA Requirements

I am very interested in this discussion as we have a non-IVD that has attained CE Mark and will be submitted to FDA in the next year. For the EU, most text was removed from the labels and all symbols are harmonized symbols from ISO 15223-1 or ISO 7000.

I am concerned about the possible need to add small text to each symbol and then have to maintain separate labeling for EU and US, or put the text on a separate label.

i just noticed that in ISO 15223-1, section 4.2, Requirements for Usage; under Note 3, it states: Symbols may be used without accompanying text. Where regulations require accompanying text, the title of the symbol given in this part of ISO 15223 should be considered sufficient.

If the FDA does in fact recognize ISO 15223-1, does this provide the coverage for not using text, or does the FDA still require it in spite of this? If so, would not just the title suffice?
 
M

MIREGMGR

#28
#28
Re: Use of Symbols on Medical Device Labels - FDA Requirements

mscottf said:
If the FDA does in fact recognize ISO 15223-1, does this provide the coverage for not using text, or does the FDA still require it in spite of this? If so, would not just the title suffice?
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My experience has been that FDA is not internally consistent regarding this. ISO 15223-1 is included in the List of Recognized Standards; however, legacy labeling guidances remain in force, and do not recognize the use of symbols (except for professional use IVDs). My understanding is that FDA's stance is that if a symbol is present on labeling, even though FDA will not recognize that symbol unless it's accompanied by subtext, the symbol must be consistent with 15223 if possible so that it doesn't miscommunicate; and this is why 15223 is included in the Recognition List.

Obviously there's a conflict between the EU multi-language requirement and the FDA English-language-subtext requirement. The company for which I work makes many products that are distributed globally. We provide symbols for world use except in USA, and English subtext for USA. So far, this approach has been acceptable to FDA, our NB, and the other world regulatory bodies with which we have come into contact.

As to what the English subtext wording should be, our approach is to use expressions that we think are consistent with common USA clinical terminology. I actually haven't reviewed them against the standard, but they're probably consistent. I'd expect some differences because (AFAIK) the standard is written in British or European English, which has some terminology and spelling differences from common American English.
 
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M

mark walker

#29
#29
Re: Use of Symbols on Medical Device Labels - FDA Requirements

You would be crazy to use text on warning labels for translation purposes, symbols where possible. If You have no option You have to make specific kits for specific countries..

Ab\nother variable is comparing 3rd edition requirements for labeling with the requirements of IEC82079-1.

iN Europe itself 15233 was published as harmonised and then withdrawn and en980 was re-instated.:rolleyes:
 
B

Bonebuilder

Starting to get Involved
#30
#30
Re: Use of Symbols on Medical Device Labels - FDA Requirements

Sorry Mark

In this dynamic, some would say confusing, world of standards you're behind the times.

EN 980:2008 "Symbols for use in the labelling of medical devices" was withdrawn on the 1st January and replaced by ISO 15223-1:2012 "Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements"

In Europe that is of course....
 
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