Changing the Name of a PMA Product Under Review

[GPjeri]

Has anyone had experience with changing your class III product name while the PMA is under review? I'm wondering if we change, will we have to submit ALL labeling with the new name BEFORE approval, or if we could get approval and submit final labeling before marketing the commercial product?

Thanks in advance for any and all replies

[Ronen E]

In Reply to Parent Post by GPjeri

Has anyone had experience with changing your class III product name while the PMA is under review? I'm wondering if we change, will we have to submit ALL labeling with the new name BEFORE approval, or if we could get approval and submit final labeling before marketing the commercial product?

Thanks in advance for any and all replies

Not a PMA expert and didn't go through this exact scenario, however --

According to this webpage:
http://www.fda.gov/MedicalDevices/De.../ucm050467.htm
you may have several options. If I were you I'd study it closely. As a general approach, I think that it's easier to address expected changes while still within the initial review period, than to finish everything up and then start all over again... especially if you already know for sure that the change is going to occur in the near future, and you have all details handy.

Cheers,
Ronen.