M
Mikeee
I have a somewhat tricky situation. My company company connects OEM's with (mostly) German manufacturers and also performs QC in between. We have a customer that supplies prints for a particular class 2 device (no 510k). The manufacturer has a 510k for a very similar part. When exporting to us, the manufacturer wants to use their FDA listing information since they have a 510k and are worried that if they use the listing information from our customer, they might have regulatory problems. However, the customer is supplying prints that the parts are to conform to and so is the "Specification Developer", and so I think that the customer's listing information should be used. I'm guessing the problem is that there may be some design overlap so that even when making the parts to the customer's prints, the parts also fall under the manufacturer's 510k (I'm speculating here).
So who's listing information should the manufacturer use when exporting?
Thanks!
So who's listing information should the manufacturer use when exporting?
Thanks!