Regulatory Open Forum

Hello Colleagues,

On the Cert to Foreign Governments, there is a statement that says: “Each product(s) identified for export is being exported from the United States.” How do you interpret this statement? Does it mean that if the devices are manufactured in China do they need to be shipped to the US first before being sold to other countries? We're getting conflicting viewpoints.

Thank you.

Mary

No, you do not need to ship China -> U.S. -> foreign client unless you want to.

The CFG regs were created to establish a "made in America" brand.  There was apprehension within the FDA that less reputable companies might use a foreigner's incorrect perception of FDA oversight to peddle substandard products abroad.

You can break this down into cases:

1)  Product made in China, shipped to foreign country, and you the U.S. company are not involved.  This is a strictly China-Philippines deal for example.  Here, the FDA clearly has no jurisdiction . Whatever regulations the Philippines & China might have apply.

2)  You, the US company import the Chinese product, put it on a warehouse shelf, and then later ship it to the Philippines.  Here, you are supposed to have the CFG.  You will have a U.S. address on the manifest.  From a practical perspective, U.S. customs might check the outgoing shipment and impound it ( they do albeit very rarely).  As such, you need the CFG.

3)  You save money and ship directly from China to your sales guy in the Philippines or possibly directly to the client.  The question you want to ask is "how is this different than 1) above".  It isn't actually.  There are a many U.S. companies that sell products or services in foreign markets.  They have to abide by local laws and regulations - and pay tax on any money brought back.  

That is the limit of the involvement.  If you think about it, Exxon might sell gas in Chile (they do actually).  They will not import the oil, refine it and formulate it comply with U.S. regulations, ship it to Chile, re-refine it and formulate it to comply with Chilean rules and then sell it. They'l refine the oil to Chilean standards at a refinery closest to Chile (possibly in Chile) and then sell. That is what you're doing.

An open question for 3) is whether you really need a CFG.  If it is a stand-alone product and not going into a kit, then technically, you do not.  Some companies are cautious and will get a CFG even though their only real contact with the transaction is the electronic transfer of funds.  

That decision is up to you.  Companies in scenario 3) that do get the CFG internally make the argument that the "made in America" philosophy behind the CFG rules propagates down to U.S. company. Those companies are being conservative.

The underlying rule:  the FDA gains jurisdiction when a medical product crosses a U.S. border, either going in or going out.   If the product, subcomponent, or ingredient never crosses a U.S. border (including a U.S. territory or free trade zone), then the U.S. FDA never gets involved.

Focusing on the product movement:

If you've opted for a CFG for a product that never crosses a U.S. border, then your company is acting conservatively.  However, a CFG is a requirement for notice to a foreign government,  It is not a customs or trade regulation.  It does not dictate that you ->must<- import a product. The FDA can't do that.(They can ->prevent<- you from importing).  

You're welcome to contact me at the address below (note the email, I'm moving servers).  We can exchange additional information, confidentiality agreements and all that other stuff.  If you really need it, I could provide you with an opinion that re-states the above (for a fee of course).

However, unless the situation is more complicated than information provided, the argument and conclusion are as outlined above. 

I've done this quite a bit.  I am surprised you're getting a diversity of opinions.

Best,

ism.