Distribution of a Device by another company - Questions about 510 (K) Clearance

Roland chung

Trusted Information Resource
#1
Hello all,

I am new for getting 510 (K) cleared. There are some silly questions. Your input will be highly appreciated.

1) Is one 510 (K) number only suitable for one manufacturer?

2) If a manufacturer would like to distribute our products using their own company name and they also want to be the holder of 510 (k) clearance, how should we do?

Thanks and kind regards,
Roland
 
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JeantheBigone

Quite Involved in Discussions
#2
Re: Questions about 510 (K) clearance

No such thing as a silly question!

1) Only one entity can be the holder of the 510(k). If you are the manufacturer and your distributor markets your product under an agreement with you, they do not require their own 510(k).

2) Be very careful with this is all I can say. I had a client who agreed to do this and a few years after the distributor got clearance for the manufacturer's product (and named them as a contract manufacturer :notme: ) the relationship between the two companies deteriorated and the distributor refused to market the product in the US. The manufacturer was stuck: they could not sell their own product until they got theor own clearance.

My advice would be to be the holder of any 510(k) if you are the specifications developer and let your distributor repackage it if they want.

:2cents:
 

Roland chung

Trusted Information Resource
#3
Many thanks, Jean. Your input is very useful for me.

......(and named them as a contract manufacturer :notme: )......
If 510(k) clearance would express the information of contract manufacturer?

The manufacturer was stuck: they could not sell their own product until they got theor own clearance
In the case you mentioned, it seems the manufacturer need to apply for a new 510(k) clearance if they want to sell their product in the US directly. That also means the manufacturer should repackage their product in order to distinguish the one which has been cleared (the holder is distributor). Is it correct?

Regards,
Roland
 

JeantheBigone

Quite Involved in Discussions
#4
Many thanks, Jean. Your input is very useful for me.



If 510(k) clearance would express the information of contract manufacturer?
Yes it appears in the cover letter, which asks for the location of manufacturing facilities.

In the case you mentioned, it seems the manufacturer need to apply for a new 510(k) clearance if they want to sell their product in the US directly. That also means the manufacturer should repackage their product in order to distinguish the one which has been cleared (the holder is distributor). Is it correct?

Regards,
Roland
Yes this is correct.
:agree:
Take care

Jean
 

Roland chung

Trusted Information Resource
#5
Hello Jean,

One more question. I just want to know that if all the documentation (including label, manual, etc) should be released in the name of distributor when the 510(k) clearance holder is distributor.

Thanks
Roland
 
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