Our company already submited and get clearance (510k) in 2018 for class II product. Is the submitted label the final one? We would like to make our label with less text than this one submitted to FDA using a insert.
Can we remove some text previous on the label and transfert to an insert? Do we need to submit to FDA the new ''cleaned'' label and the new insert? Is this kind of change an amendement to our 510k or only a notification? We searched at the regulation/requirement and it was not clear how to proceed with this change.
Good morning monoj,
Thanks for your feedback.
We looked at the Annexe A, but the change we want to do is not part of the multiple choice. Your question: Please elaborate, what do you mean by "less text" on the label. What are the types of text you are planning to relocate!
Our label is very condensed in term of too much text on it, and hard to read. We would like to transfert certain texts to an insert. No change in the content. We will keep the symbol on the label beacuse there are only two. Sections as Precautions and Warnings, Adverse Events and Handling and Disposal and Instruction for usewe want to relocate to the insert.
Any way to do this? Thanks
I wouldn't have placed those on the label at the first place, rather I would use the IFU to include these sections . Anyway, shorter way could be evaluate the changes based on that guidance, do some risk analysis, make sure that you reach into a "Documentation" conclusion and place a sentence on your label saying that those sections are now available in the accompanying insert. However, this is just my opinion and I don't have any such prior experience similar to your case. If you are still in doubt then I would recommend to talk to a consultant or talk to FDA directly. Good Luck.