Updating Certificate of Foreign Government (CFG's)

Qara123

Involved In Discussions
Is it right that as long as the applicant's company meets QSR and manufacturing site resides in US, they can apply for CTFG for any medical device?


red_wood,

1) The company has to be registered with the FDA and passed an FDA inspection. I agree with MIREGMGR that the inspection date is irrelevant (but is necessary in the application process) as long as no outstanding issues were found.
2) The manufacturing site does not have to reside in the US but I think the applicant has to be the PMA holder.

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red_wood

Thanks MIREGMGR & Qara123.

Most of my company's products are low class devices where majority are 510 exempt with a few requires 510K and none needing PMA. Due to the low risk, the company has never been audited by FDA. Given so, are we still eligible to apply for CTFG?

Our distributor is asking for CTFG from FDA to support product registration (in Argentina). We, on the other hand, do not want to alert FDA to audit the company via a CTFG application.

Any advice? Thanks!
 
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MIREGMGR

...the company has never been audited by FDA. Given so, are we still eligible to apply for CTFG?

As far as I know, yes. My interpretation of the rule is that you need not have passed a QSIT inspection; rather, you must not have failed your most recent one. No inspection = no failure.

We, on the other hand, do not want to alert FDA to audit the company via a CTFG application.

Assuming that your company is legally registered as an Establishment, you're already in the inspection database. Nothing further that you do in an affirmative sense will raise your inspection-likelihood profile. I don't know the specific scoring system that's currently used, but I think an argument could be made that compliance-oriented actions taken by you, rather than raising your inspection likelihood might actually lower it, since they would serve as evidence that you are following the rules on your own.
 
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nwong

I have a question myself regarding the Product Information section of the CFG. It asks for the product's Trade Name and its Proper Name. The Trade Name is just the name we are selling it as correct? And for the Proper Name, is it necessary I put down what's listed on the 510k? or is that not necessary and a general description would suffice?

Thanks in advance!
 
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MIREGMGR

Trade name = brand name or marketing description

Proper name = generic/technical description
 
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markvm68

A second question concerning CFG's. We purchased a company a few years back and they had their own quality system. The company name is the same now, we just differentiate by location. They have a line of products they sell under a five digit catalog number which we are now going to begin packaging at our corporate office. Unfortunately, we only have a CFG that shows their location and not our corporate location. Can we export under their CFG, even though the address on the CFG won't match the address on the product label?

We are in the process of updating our CFG to cover the other locations catalog numbers, but we are wondering what to do in the time it takes to get this done.

Thanks for your input.
 
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PCoronado

I have a question about CFGs, too. The FDA 3613 form says the following as one of the requirements: "Each product(s) identified for export is being exported from the United States." Is a product manufactured in another country for a U.S. firm by an FDA registered facility "exported from the United States?" It doesn't seem so to me. Is there a subtlety such as legal manufacturing site vs. actual manufacturing site?
 
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MIREGMGR

I have a question about CFGs, too. The FDA 3613 form says the following as one of the requirements: "Each product(s) identified for export is being exported from the United States." Is a product manufactured in another country for a U.S. firm by an FDA registered facility "exported from the United States?" It doesn't seem so to me. Is there a subtlety such as legal manufacturing site vs. actual manufacturing site?

My understanding is that legally, FDA regulations are based on FDA definitions of product origin, not Department of Commerce definitions. Thus it's common and permissible for a medical device to be simultaneously labeled Manufactured By (Company X at a US address) (per FDA regulations) and Made In (Country Y) (per Department of Commerce regulations).

FDA regs define who is the Manufacturer of a device, and the responsibilities of that party. The Manufacturer need not be the actual maker of the device; that instead might be a contract maker, located in the US or elsewhere. The Manufacturer however must be located within the US in order to be eligible for the CFG program.
 
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