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.
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.