Symbol Colours and Sizes on Medical Devices

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Z

zhang126

#12
In MDD 93/42/EEC,
ANNEX I
ESSENTIAL REQUIREMENTS
...
..
.
13.2. Where appropriate, this information should take the form of symbols.
Any symbol or identification colour used must conform to the
harmonized standards.
In areas for which no standards exist, the
symbols and colours must be described in the documentation
supplied with the device.
 
M

MIREGMGR

#14
(...) although i think FDA recognizes the EN 980 fonts (Symbols for labeling medical devices).
It's hard to tell, when one is informed of "the FDA's stance" or "interpretation" during the 510(k) process by an examiner, whether the information being presented is idiosyncratically unique to that examiner or actually "the FDA's stance". That notwithstanding, we have been told by two FDA examiners now that EN 980 and ISO 15223 specifically are not recognized.

One of those two examiners then told us that the only symbols the FDA will accept on device labels without explanatory and self-sufficient subtext (in English only) were those that are defined in the IVD labeling guidance (whether or not the device in question is an IVD).

The other examiner told us that the FDA will not accept any symbol on a non-IVD medical device label, or elsewhere on the device, without explanatory and self-sufficient subtext in English only.

Note that in both cases, definition of the symbol elsewhere in an IFU or other accompanying information was not acceptable. The information had to be on the label, where the symbol appears.

I asked the second examiner how one would be expected to meet international labeling requirements in regard to multiple languages and symbol preference, and was told that the FDA does not consider regulatory requirements outside of the US to be relevant to US requirements.

It's generally known, I think, that there is an internal conflict within the FDA between what I would call the pro-harmonization faction, which includes Tim Ulatowski of CDRH, and a traditionalist faction. My impression is that the 510(k) examiners' office must be in the latter camp.
 
R

RetroVirus

#15
i have heard about instances that MIREGMGR spoke about - but in my work experience within companies whose labelling of FDA approved products carried symbols on the device labelling, the FDA inspector who subsequently audited us never mentioned anything against the use of symbols and certainly nothing was mentioned by the 510(k) reviewers.

i did not work in the regulatory side of these companies but i do know that labelling with symbols (i can now post the url below) were indeed acceptable as long as a glossary is provided in the IFU/manual. certainly this is true for small labels in which full text would be either difficult to print or too small to read. Note though that the guidance reads:

"FDA recognizes 25 symbols for IVD devices for professional use from the following two international consensus standards:
*ISO 15223, Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied
*EN 980, Graphical symbols for use in the labeling of medical devices"

the symbols that the companies i worked in used were within the recognized symbols. the approval of FDA guidance though expired in 2007 and no replacement has been published by the FDA. perhaps that is what the examiners (of the poster above) were siding with either that of the symbols being used were not any of the 25 recognized by the FDA.

http://www.fda.gov/downloads/Biolog...toryInformation/Guidances/Blood/UCM085430.pdf

RV

It's hard to tell, when one is informed of "the FDA's stance" or "interpretation" during the 510(k) process by an examiner, whether the information being presented is idiosyncratically unique to that examiner or actually "the FDA's stance". That notwithstanding, we have been told by two FDA examiners now that EN 980 and ISO 15223 specifically are not recognized.

One of those two examiners then told us that the only symbols the FDA will accept on device labels without explanatory and self-sufficient subtext (in English only) were those that are defined in the IVD labeling guidance (whether or not the device in question is an IVD).

The other examiner told us that the FDA will not accept any symbol on a non-IVD medical device label, or elsewhere on the device, without explanatory and self-sufficient subtext in English only.

Note that in both cases, definition of the symbol elsewhere in an IFU or other accompanying information was not acceptable. The information had to be on the label, where the symbol appears.

I asked the second examiner how one would be expected to meet international labeling requirements in regard to multiple languages and symbol preference, and was told that the FDA does not consider regulatory requirements outside of the US to be relevant to US requirements.

It's generally known, I think, that there is an internal conflict within the FDA between what I would call the pro-harmonization faction, which includes Tim Ulatowski of CDRH, and a traditionalist faction. My impression is that the 510(k) examiners' office must be in the latter camp.
 
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