We recently submitted a 510k to the FDA for a ob/gyn cell collector. The product is single use and will only be utilized by doctors in a professional setting (will not be available to the public).

We followed the FDA "Guiance for Insustry and FDA Staff-Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use". We included the symbol on the label with a "2" with a circle and slash through it to distringuish this item as a single use item, as well as an hour glass for expiration date, and a symbols for see instructions for use.

We received a letter from the FDA with some concerns about the labeling which state "device labels include non-recognized symbols for single use only, see instructions for use, and expiration date. Please replace these symbols with text".

The request may seem simple to replace with text but our labels have mutiple languages and are relatively small and we want to keep everything clear. We do plan on complying with the FDA request.

We reviewed other devices that our similar to ours that used the same symbols. We thought that FDA document would be applicable to our device but now we are wondering why the FDA would say the symbols are non-recognized. Any insight would be helpful.:confused:

Sounds like you did what you were supposed to do. I found this link to a guidance that seems to affirm the symbols you used:

http://www.fda.gov/cber/gdlns/ivdlabel.pdf

I think I'd have to ask for clarification.

Is the cell collector invasive? If so, then the guidance mlabardi has referenced is not appropriate, as it applies to IVDs only.

The whole labelling thing has always been a sore issue, so I'm interested in what the current FDA position is, and what the future might be.


European love symbols, because of the many languages within the EU, and the space savings that entails. Over time, users have learnt what the symbols mean too (no small importance!).

But these factors are less critical in the US, where English is the main language, and users have little experience with many of these wierd symbols.

Of course there IS a problem when it comes to IVDs, since many of these products are tiny. So it is actually interesting (and positive) that the FDA has bought into the use of symbols for those devices.

Possibly FDA is considering letting the IVD symbols become established, then allowing IVD dual-labelling (symbols and text) for a few years, and finally allowing symbols only where appropriate.

If anyone has some up-to-date information, that would be appreciated.

I have moved this thread to the FDA section.

We have successfully submitted Medical Device 510k's for ages using EN980 symbols.

Just this week I had a 510k rejected because the Food and Drug Administration say they want text as well as the symbols.

Is this a new requirement or are the Food and Drug Administration being picky?

Approximately a year ago, we were told by Terrell Cunningham, an FDA 510(k) examiner in the Office for Device Examination (ODE), in regard to one of our 510(k) submissions that the referenced FDA guidance document was the current FDA standard for symbol acceptability.

In our original submission, we had used a symbol from either EN980 or EN ISO 15223-1 that one of our European customers had requested be on their worldwide-distribution label, but that was not included in the IVD-document set. We were directed either to provide English subtext or to replace that and any other non-IVD-set symbol.

I think we know from other evidence that there's something of a turf war within FDA between the USA-only traditionalists and the global-harmonization fans, among whom are Tim Ulatowski, Margie Shulman and others from CDRH's Office of Compliance. I think that dispute or turf war is why, for instance, the previously Tim-Ulatowski-publically-discussed program under which an ISO 13485 audit report would be accepted by the FDA as a substitute for an FDA-conducted first-tier QSIT-1 field inspection program (http://www.fdanews.com/newsletter/article?issueId=12079&articleId=111588), supposedly "to be announced soon", hasn't been heard from since.

My understanding is that the FDA's global-harmonization faction envisions that eventually the FDA's first-tier QSIT-1 inspection effort might be entirely replaced by the FDA medical-devices world being required to be certificated to ISO 13485 (and much more frequently audited, at their own expense, than the FDA can manage at no cost to the inspected firms given their field resource limits), with the FDA providing the legal backup to write 483s based on ISO audit reports and subsequently providing only the inspections-for-cause.

I've heard that perhaps some of the higher-ups in the Office for Regulatory Affairs (ORA, which manages the large field-inspection hierarchy, almost half of all FDA personnel) and the upper FDA heirarchy below the politically-appointed level are on the other side of that dispute.

My guess is that this symbol issue, coming to us through the ODE, is a facet of that internal global-harmonization-is good/global-harmonization-is-bad argument, which is related to the future of the FDA's field-inspection role.

Hello,

As i know, the symbols you mentioned above are originated from EN harmonized standard, EN 980. Maybe FDA does not accept these symbols as general ones which could be recognized by American public.

And as your products are intended to be distributed in USA, why you have to include multi-language information in the label.

:D:D

Alex