Hi Everyone

We are a manufacturer of a Class I Medical Device and are currently in the process of updating our packaging. Can anyone tell me if the federal warning label needs to be on both the inner and outer packaging of our device? It is currently on both but we are trying to decide if we can take it of off the inner pack.

Your help and advice is needed please !!!

Thank you

RA Princesss

Welcome:)


Laws be ****ed, keep the warning labels on both. Is it a cost issue?

Al...

Hi Al

Thanks for your quick response. :)

Its a product that we are only now wanting to take to the US market and are struggling to find space to fit it on the inner pack label along with all the other information needed.

Is it written in stone that it needs to be on both? My thoughts are that as the product will still be double wrapped when chosen / selected by the surgeon for a procedure and taken to theatre and will therefore still show the warning, once in theatre it will be taken out of the outer pack but the warning isnt relevent any more and dosent need to be on the inner pack.

I hope I'm making some sense!

RA Princess

Does anyone know what the law actually states? Or if there is a defining law / regulation?

Princess,

Without knowing the device, I would hesitate to comment. Look at Labeling Requirements (http://www.fda.gov/cdrh/devadvice/33.html) in FDA's Device Advice (http://www.fda.gov/cdrh/devadvice/), then you can make your own determination.

I agree with Al with the addition of the following link. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm or at http://www.fda.gov/cdrh/devadvice/313.html.
I would then search to to determine that the FDA concurrs that the device is Class I and the restrictions/excemptions they may have.

Is you warning label a part of your Instructions for Use?
If you are currently having the warning label multiple places, why and why change?