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510(k) registration and listing

Alyana

Starting to get Involved
#1
Hi Cove,

Given a foreign manufacturer A is registered with US FDA and having a list of its 510 (K) product. Can the foreign manufacturer A register additional products using 510(k) of another foreign manufacturer B.

Thanks.
 
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monoj mon

Quite Involved in Discussions
#2
Can the foreign manufacturer A register additional products using 510(k) of another foreign manufacturer B.
Yes, it can be done. But you will need to define the specific responsibilities appropriately. For example, if the Manufacturer B physically manufactures the product for the Manufacturer A, then the Manufacturer B shall be listed as "Contract Manufacturer" for that specific product and the Manufacturer A shall also declare its role accordingly. Both A and B shall also link the original 510(k) of that product to their listing.
 
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