Recommendation for US Agent Services for Medical Device Companies

[Julie O]

Can anyone recommend a company that offers US Agent services for medical device companies?

This is for a very small UK company that currently plans to market only one device in the US. It would prefer a smaller firm that specializes in this service, rather than a larger firm that offers it as one of a wide range of services. Here are two examples:

http://fdaagents.com

http://www.usagentservices.com

 

[shimonv]

Hi Julie,
The role of U.S. agent is very focused and limited in scope.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

I don't see how a larger or a smaller firm would make much of a difference. I'm also assuming, judging by the size of the company you are describing, that the product is not a class III device which would attract a lot more attention.

If they want to save expenses, they can explore the option of appointing an individual to represent them. The following is an extract from FDA FAQ on the subject:

"11. Can an individual represent a foreign establishment as its U.S. agent and its official correspondent?
Yes, but as the U.S. agent, the individual must reside or have a place of business in the United States. No post office, lock or mail service drop boxes are allowable. The address must be for a physical location where the U.S. agent can be visited by FDA staff."

Shimon

 

[Julie O]

I think the size of the company is not the issue, but the focus. There are many firms that offer this service in conjunction with other services for which they bill at hundreds of dollars an hour, where US Agent service is typically available for only a few hundred a year. So the thought is (and I have seen this myself) that this type of firm is likely to want to market their other services to them as well. The company has lined up all the other services it needs, and would prefer to keep it simple.

I don't know if they know any individuals in the US, but there are potential liability issues associated with this service, so I wouldn't recommend it. The role may be very focused, but the underlying purpose is to provide the regulatory agency a target for legally valid service (as in "you've been served") within its legal jurisdiction. The US Agent could receive warning letters, cease and desist orders, etc. As an agent of the company, things could get uncomfortable for them if the company they represent should fail to comply with local laws. Conversely, if a company claimed that it didn't receive something the regulatory agency sent to the US Agent, other problems could arise. Businesses have insurance coverage that individuals are unlikely to have.

 

[Ronen E]

I think that this might be a good option (need to check that US agent services are actually offered).

 

[Julie O]

Thanks, Ronen, but they really want a firm that primarily offers US Agent services, not regulatory or quality or legal services. If you look at one of the two links, I provided, you will see what I mean.

I'm hoping someone here might have used one of these services, or a very similar service, and can tell me how that went. They seem to be very virtual companies, so it's hard to know if they are even legit.

 

[Ronen E]

Thanks, Ronen, but they really want a firm that primarily offers US Agent services, not regulatory or quality or legal services. If you look at one of the two links, I provided, you will see what I mean.

I'm hoping someone here might have used one of these services, or a very similar service, and can tell me how that went. They seem to be very virtual companies, so it's hard to know if they are even legit.

Seems to me like an unnecessary complication. All companies I know that offer US agent services (big or small, including one man shows) do so on top of offering other services, typically regulatory. I'd find it hard to imagine anyone making a living solely from US agent services (but then it might be just my limited imagination ). If one also rules out engaging a natural person (ie an individual) then not much is left in between.

 

[Julie O]

Did you click on either of the two links in my original post?