510(k) Questions - Do we as the middle-man have to have one?

[slice]

We are operating as a middle-man in distribution of a Class II medical device in the U.S. We are receiving an unfinished product from a customer and sending it to one of our suppliers to finish the product and then we are sending it back to our customer in the finished state.

I am sure the customer would need to have a 510(k) to sell in the U.S.

My question is do we as the middle-man have to have one? Does our supplier performing the finishing touches on the product and sending it back to us have to have a 510(k)?

Your help is greatly appreciated!!! Thank you!

 

[JeantheBigone]

We meet again!

Unless the device is 510(k)-exempt, somebody has to own a 510(k) for it. Once that 510(k) is in place, the other parties involved may or may not have to register and list using the K-number.

I'm not clear on what you mean by "finishing touches," but it is conceivable that this could be a justification for that supplier to be the 510(k)-holder.

If your entity is a U.S. representatives of the foreign manufacturer/exporter then it could also be the 510(k)-holder. Just please be aware that holding a 510(k) brings an obligation to be inspected. Other parties who register and list are also subject to inspection. This has been in my experience the number one reason why foreign manufacturers try to avoid the 510(k)-process and let someone else handle it.

Premarket Notification 510(k)