Design History File - Not ready to share the design drawings or Bill of Material

#1
Hi,
My client is planning to go for a 510(K) approval of a product which is manufactured by an other company 'A'(who owns the complete technology) and is not ready to share the design drawings or Bill of Material to my client.
As I understand, my client who is going to be the potential owner of the 510(k) must maintain the complete DHF in his quality management system. Company A must register with FDA as a contract manufacturer. What are the options available so that it could be a win win situation for both (My client and the company).
I assume, the private label will not work here as my client is not purchasing a already approved product. My client will own the 510(k) and distributorship of the product.


Appreciate your thoughts.

Thanks,
 
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#2
Sounds like a scary situation. I think your client is not in a position to submit a 510K.
If Company A does not want to share details of device design, they should be the ones to submit the 510K and your client can then be the relabeler.
It was Company A who developed the specifications for the device, right?
 
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