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Distributor requirements in US

#1
I have searched and can not find a definitive answer on this for US. My company wants to distribute needles and syringes, class II devices. We are only distributing, label does not have our name (manufactured in China). Manufacturer is registered and has 510k. I received the product samples and there is no UDI. Can I distribute? I would think not as it’s not approved for distribution in the US due to the lack of UDI but has 510k. What are my requirements/liability for distributing unapproved product?
 
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shimonv

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#2
Hi soreillyasp,
Welcome to the cove. Sample products (not for human use) are not required to have UDI.
You should ask the manufacture about it. I would not distribute a product when I know for sure that it does not meet one of the FDA regulation.

-Shimon
 

monoj mon

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#3
I received the product samples and there is no UDI. Can I distribute?
When someone sends samples from outside the US, usually a sentence such as "samples only, not for human use" should be written on it. And you are not supposed to distribute it for human use. The product meant for distribution will have proper UDI on it.

I am curious to know what do you mean by this! We also send our devices to the US for distribution and I expect my client in the US would ask me 'samples' for quality check only, not for distribution.
What are my requirements/liability for distributing unapproved product?
 
#4
Sorry let me clarify. The manufacturer sent me samples of finished product with the labeling (it is product that they already make) that are not for distribution. The samples were for me to review to determine if I would like to place an order. The samples and therefore the finished product does not have the UDI
 
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