(...) 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.