At what point do you need to identify a U.S. Agent - 510(k)

Le Chiffre

Quite Involved in Discussions
#1
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?
 
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M

MIREGMGR

#2
Re: At what point do you need to identify a U.S. Agent

The requirement for an agent is derived partly from the incident reporting expectation, and partly from convenience in operation of the reguatory-filings system.

Certainly this responsibility could be shifted to a distributor, but some non-US manufacturers prefer to maintain a separation between their sales and marketing dealings with their distributor, and their regulatory affairs issues handled through their agent.

Such an approach obviously allows more flexibility, for instance in regard to management of sales and marketing expectations.
 

Le Chiffre

Quite Involved in Discussions
#3
Thanks, that's a tactical decision we'll have to make.

My initial concern was whether this has to be sorted out before the 510(k) clearance - is it a prerequisite to filing?
 
M

MIREGMGR

#4
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?
In theory, the latter.

You declare your agent when you register your establishment and list your products using the DRLM/FURLS site.

Normally establishment registration and product listing occurs after a 510(k) is granted. A Class II product cannot be listed without knowing its 510(k) number. Thus the above order.
 
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