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Hello all and thanks in advance for any advice.
We have two separate legal entities doing business under the same name, ABC is located in the US and XYZ is located outside of the US. For a particular line of products, ABC has developed the specifications for XYZ. XYZ manufactures the product and exports the product to ABC in the US, where ABC then distributes the product with their own name/address listed on the product (no other operations are performed on the product).
My questions are?
Does this make XYZ a contract manufacturer? According to the FDA?s website a contract manufacturer ?Manufactures a finished device to another establishment's specifications.? However when I go to re-register on the DRLM site the check box for contract manufacturer states, ?Manufacture and Distribute Medical Device for Another Party.? According to the first Definition XZY is a contract manufacturer, but according to the second definition it is not. Am I missing something here?
We have two separate legal entities doing business under the same name, ABC is located in the US and XYZ is located outside of the US. For a particular line of products, ABC has developed the specifications for XYZ. XYZ manufactures the product and exports the product to ABC in the US, where ABC then distributes the product with their own name/address listed on the product (no other operations are performed on the product).
My questions are?
Does this make XYZ a contract manufacturer? According to the FDA?s website a contract manufacturer ?Manufactures a finished device to another establishment's specifications.? However when I go to re-register on the DRLM site the check box for contract manufacturer states, ?Manufacture and Distribute Medical Device for Another Party.? According to the first Definition XZY is a contract manufacturer, but according to the second definition it is not. Am I missing something here?