Can a US manufacturer put export only products on a CFG?

#1
Explanation: We are a US based manufacturer and we manufacture some products for European sales only. Can I place items that aren't for sale in USA (can't be marketed in USA), that don't have a 510K, on a CFG I'm generating for our European distributors?

The only reason I'm asking is because the CFG's say "It is certified that hte above product(s) may be marketed in, and legally exported from, the United States of America at this time" and in this case, the product can legally be exported from US but can not be legally marketed in US.

Does anyone know what document I would use to certify a line of products not for sale in US but that is for sale in Europe similarly to how the CFG certifies the product?

Thank you!
 
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#2
I am located outside the US and so have limited experience with CFG. But, what I guess is that you should be able receive a CFG. Being a "Us Manufacturer of Export Only" devices, the FDA requires you to "Registrer" your establishment, "List" your device and "Pay" the annual fee. That means, you should have a FURLS account from where you will be applying the CFG. What I assume, since you have registered, listed and paid the fee you shall be good to go to apply for the CFG.
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The only reason I'm asking is because the CFG's say "It is certified that hte above product(s) may be marketed in, and legally exported from, the United States of America at this time" and in this case, the product can legally be exported from US but can not be legally marketed in US.
The CFG also says "The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above" :cool:. So, I guess this is true in your case and the FDA already has your information in their database. When you apply through the "FURLS" account, there should be step by step guidance regarding what kind of documents/information you would need to submit (if any). I have never applied CFG by myself, so I am not familiar with what exact documents you would need.
 
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