Signal Words for CE Mark and FDA Labels

[theola]

We are planning to sell a medical device in the EU and the USA.

Is there a possibility to design labels in a way that they are compliant to FDA and EU regulations.

In detail:
Our medical device contains chemicals that require warning symbols on the label. This can/must be used within the EU. As far as I know for the US market only signal words are allowed (e.g. toxic) and no warning symbols. As our labels small we are not able to place both versions on it.

Does someone know a guidance or standard which refers to this topic or has any advice.

Thanks

[Ronen E]

In Reply to Parent Post by theola

We are planning to sell a medical device in the EU and the USA.

Is there a possibility to design labels in a way that they are compliant to FDA and EU regulations.

In detail:
Our medical device contains chemicals that require warning symbols on the label. This can/must be used within the EU. As far as I know for the US market only signal words are allowed (e.g. toxic) and no warning symbols. As our labels small we are not able to place both versions on it.

Does someone know a guidance or standard which refers to this topic or has any advice.

Thanks

Hello and welcome to the cove

Have you already looked at this:

http://www.ghtf.org/documents/sg1/sg1final-n43.pdf

Cheers,
Ronen.

[Dudes]

For the US, you are allowed to have the symbols but you must have the english wording as well. This can be done on the same or on a separate label.

It is however difficult to give you more precise advice without knowing the type of device you are referring to.

Maybe this can help: http://www.fda.gov/MedicalDevices/De...ng/default.htm

[theola]

Thanks for your quick reply. I read through the guidelines.

Our product is an in vitro diagnostic, thus 21 CFR Part 809 applies.
Our product contains substances that are e.g. corrosive.

at dudes your comment:
"This can be done on the same or on a separate label".

Does this also mean that could place only the symbol for corrosive on the outer box label, and describe the symbol in the instructions for use respectively (We want to avoid to put two labels on the outerbox)?

As far as I interpret the GHTF guideline this could be possible, however if I read through 16 CFR part 1500 it sounds like I have to write the statement "corrosive" on the outerbox.

Regards
Thomas

[The Specialist]

Perhaps you could use different labels for different markets?

[Dudes]

I can't say for sure, as I'm not familiar with IVD devices.

However, AFAIK, describing the symbols on the instruction for use isn't enough. The second label would have to be on the outer box

[MIREGMGR]

In Reply to Parent Post by theola

Does someone know a guidance or standard which refers to this topic or has any advice.

I assume that your devices are intended for professional use.

Are you already using Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use ?

In any case, US FDA does not forbid international symbols from labels, unless they're misleading, conflicting or false. FDA's stance instead is that (except for professional IVD users) US device users aren't sufficiently familiar with the full range of standardized symbols, therefore FDA will ignore any symbols and review only whatever English text is present.

Additionally, note that a number of federal and state workplace-safety laws and regulations pertaining to chemical handling require the use of chemical safety symbols.

[MIREGMGR]

Heh. OK, I didn't recognize 16CFR 1500 above, so I checked. That's a CPSC (Consumer Product Safety Commission) reg.

If your IVDs are intended for sale direct to consumers, my post above is entirely invalid.

And, note that nothing published by US FDA has any bearing on CPSC regs, which are under the Department of Commerce. Two entirely unrelated regulatory environments.