I'm in the process of filing a 510(k) (currently waiting for a user fee ID). As a foreign manufacturer, when will I be required to identify a U.S. Agent, before the 510(k) is reviewed or before I can start importing the device?
Eventually, I hope this role will be filled by a distributor but until a 510(k) is obtained, the discussions with distributors are rather short. What's the approximate fee for this service when the device is likely only to be exposed to a single "lead customer". Is it normally a retainer plus time arrangement?
Eventually, I hope this role will be filled by a distributor but until a 510(k) is obtained, the discussions with distributors are rather short. What's the approximate fee for this service when the device is likely only to be exposed to a single "lead customer". Is it normally a retainer plus time arrangement?