510(k) holder for a foreign manufacturer

[elopez]

Can a US Distributor act as a 510(k) holder for a foreign manufacturer? The foreign manufacturer does not want to be the 510(k) holder and plans to designate the US Distributor to also be their US Agent. A license agreement will be in place that will clearly define the roles and responsibilities. In the 510(k), the US Distributor would be listed as the US Agent. The foreign manufacturer will be identified as the contract manufacturer, and labeling will reflect "Distributed by or Manufactured for." All parties involved will follow FDA establishment and product listing requirements, where applicable. Would the FDA have any issues with this approach?

 

[Enternationalist]

I'd assume it works similarly to a PMA - the sponsor holds the PMA and right to market the device, and that sponsor may not necessarily be the contract manufacturer. That said, you'd need to be able to have the foreign manufacturer under contract to provide all necessary resources to fulfill the 510(k) process - that is, they'd still basically be subject to all of the requirements, it'd just be via you.

It seems like it's possible - but I imagine it's rare for a very good reason.

So the question is, why don't they want to be the 510(k) holder? Because if the answer is that they don't want to bother meeting FDA requirements, I'm not convinced this arrangement is going to help anybody.

If you want to be 100% sure, though, ask the FDA. I'd show them the full plan for the quality management system and who is performing which duties, and who is listed, paying fees, subject to audit, etc.