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Certificate of Free Sale

Udirn1

Starting to get Involved
#1
Dear All,
I have a few questions that I would love to gain insight on:
1. If I were to manufacture my Medical and or non Medical products in the USA instead of Europe and sell them all over the world, can I obtain a CFS or a like by the US entity so I could provide to the destination country upon request?, is that something that could be done?
2. Must I have an FDA approved device in order to be able to manufactured in the USA or I can manufacture anything even if its not FDA cleared ?
Thanks
Udi
 
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monoj mon

Quite Involved in Discussions
#2
1. If I were to manufacture my Medical and or non Medical products in the USA instead of Europe and sell them all over the world, can I obtain a CFS or a like by the US entity so I could provide to the destination country upon request?, is that something that could be done?
Yes, that is the procedure usually followed, and you can get your Certificate to Foreign Government (CFG) from the FDA by using your FURL account. Once you log in you will see the CDRH Export Certification Application and Tracking System (CECATS) module. Using that module, you can apply for your CFG.
2. Must I have an FDA approved device in order to be able to manufactured in the USA or I can manufacture anything even if its not FDA cleared ?
Thanks
You must follow the appropriate regulatory pathway for your device based on its product code in order to bring it into the interstate commerce. But, before bringing it into the market, you are free to manufacture your device. However, I would advice you to do research on the applicable regulatory information for your device. There are topics you must understand prior to start manufacturing your device. Otherwise, once you try to notify FDA about your intention to sell the device, you might face unforeseen regulatory hurdles. You must, at least, follow 21 CFR 820 and its underlying sections.
 

Udirn1

Starting to get Involved
#3
Hi
I appriciate your response.
Can I only manufacture my devices in the USA without selling them domestically nor to register them with FDA and still apply for CFG? (I wish only to manufacture in the usa and export the devices)
Thanks
Udi
 

monoj mon

Quite Involved in Discussions
#4
nor to register them with FDA and still apply for CFG?
No, if you don't register your facility and list the device you are manufacturing to sell it to other country, then why would FDA issue a "CFG" on your behalf! :) See the below image from this link. You don't need to go for a 510(k)/IDE/PMA submission in this case, but following the regulations required by the FDA to issue you a CFG is a must.
1606105483520.png
1606105458989.png

See below a template for CFG (although it is from CBER). Being "US Manufacturer of export only devices" you are subjected to "periodic inspection" bu the US-FDA. There is no provision to skip it.

1606105812069.png
 

Udirn1

Starting to get Involved
#5
Hi
I am sorry I was misunderstood.
I plan to manufacture my devices in an FDA registered and legit facility which manufactures different devices.
However, the devices I will be manufacturing can only be exported and not sold domestically, as I do not wish to go through 510k.
Under these circumstances would I be granted a CFG should I require it for foreign country's?
Thanks
Udi
 

Udirn1

Starting to get Involved
#7
Thanks.
I went over the CFG and saw the following:
.."it is certified that the above listed products may be marketed in, and legally exported out from the USA....."
The words "marketed in" stand in contradiction to the fact the the device has to go through 510K, or am I missing something?
Another small question, if the device I am to manufacture in the states is not considered as medical device under the FDA does the same path apply?
Thanks for all your help
Udi
 
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