Q
I recently started at a new company (headquartered in Germany) and dicovered that they submitted a 510k for a device that is 510k exempt. And now we are in the final phase of developement on a new 510k exempt device and top management is asking if we should do a 510k, stating that there may be some industry advantage to having a 510k approval letter from the FDA. I see no market advantage at all to having a 510k on an exempt device; am I wrong? 