Regulatory Open Forum

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

​Hi Maddi.

Let me make sure I understand your situation before giving you anything further.  From my reading it sounds like the specification developer/owner of the product is based outside of the US.  They have contracted with a manufacturer who is not in the specification developer/owner's country.  You are questioning whether or not you need to list the manufacturer as the exporter to the US or if it is sufficient to list the specification developer/owner as the foreign exporter.  You also don't note whether or not you are working on a device, drug, biologic, or combination product.  Since you are speaking of specification developers this has traditionally meant devices I am going to assume that your product is classified as a device (or at least a combination product for which CDRH has lead center jurisdiction).

I come at this from the pharmaceutical perspective and have honestly not yet encountered something like this in my experience.  My gut reaction to this is that the specification developer/owner is actually taking the responsibility for the product generally and therefore it would be logical and reasonable for you to list the specification developer/owner as the foreign exporter of the product.  The question becomes then whether the foreign specification developer/owner actually performs the acts of export or if they "drop ship" to the US from their equally foreign manufacturing site?  To me it should not truly make a difference.  However, unless you are certain that the specification developer/owner is capable of providing further details of the transactions that they perform and those actions the manufacturing facility actually performs, it becomes a bit more muddled in my opinion.

So short answer is that in my very unexpert opinion, you should be able to provide the name and address information of the specification developer/owner of the product as the foreign manufacturer.  They should be managing their supply chain sufficiently to manage the requirements of the regulations if they have been approved to sell their product in the US.  If you are in the process of going through that approval (again your original post was silent on that point) you might want to get a directed response from the review team on that point.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

Maddi,

I have always the "Foreign Exporter" understood to be the facility or facilities that physically handles the device, which is most times the manufacturer/contract manufacturer.  As an example, if your parent company is located in New York and you have a contract manufacturer in say Germany, they would be considered the Foreign Exporter if sending product to your facility from Germany to New York.  If you read the definition it says '... ​device manufactured, prepared, propagated, compounded, or processed in a foreign country ...' so would be a facility that I have always understood physically manipulates the device.  Just note that if you have more than one facility outside U.S. doing physical processing of the device, there may be more than one facility that must register including (using previous example) if you send various bits to Germany and they assemble and test a finished device to send back to your facility in New York.

A Specification Developer that your organisation is using outside the United States should also be registered according to the FDA requirements, but to me there is no designation whether this is a facility located in the U.S. or outside the U.S.  When a company as a Specification Developer registers they will just list the address of their place of business.  Involved in design and development activities for me does not constitute 'manufactured, prepared, propagated ..' etc. to be considered a Foreign Exporter.  By definition a Specification Developer does not perform any manufacturing, so I have also used that in my experience to not check the box as Foreign Exporter.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 03-Dec-2018 15:51
From: Victor Mencarelli
Subject: Who can be the Foreign Exporter according to FDA?

​Hi Maddi.

Let me make sure I understand your situation before giving you anything further.  From my reading it sounds like the specification developer/owner of the product is based outside of the US.  They have contracted with a manufacturer who is not in the specification developer/owner's country.  You are questioning whether or not you need to list the manufacturer as the exporter to the US or if it is sufficient to list the specification developer/owner as the foreign exporter.  You also don't note whether or not you are working on a device, drug, biologic, or combination product.  Since you are speaking of specification developers this has traditionally meant devices I am going to assume that your product is classified as a device (or at least a combination product for which CDRH has lead center jurisdiction).

I come at this from the pharmaceutical perspective and have honestly not yet encountered something like this in my experience.  My gut reaction to this is that the specification developer/owner is actually taking the responsibility for the product generally and therefore it would be logical and reasonable for you to list the specification developer/owner as the foreign exporter of the product.  The question becomes then whether the foreign specification developer/owner actually performs the acts of export or if they "drop ship" to the US from their equally foreign manufacturing site?  To me it should not truly make a difference.  However, unless you are certain that the specification developer/owner is capable of providing further details of the transactions that they perform and those actions the manufacturing facility actually performs, it becomes a bit more muddled in my opinion.

So short answer is that in my very unexpert opinion, you should be able to provide the name and address information of the specification developer/owner of the product as the foreign manufacturer.  They should be managing their supply chain sufficiently to manage the requirements of the regulations if they have been approved to sell their product in the US.  If you are in the process of going through that approval (again your original post was silent on that point) you might want to get a directed response from the review team on that point.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

Hi Maddi
I have also recently had challenges in understanding what role is appropriate for a particular company's registration.  My client has a contract manufacturer that holds a registration as a foreign exporter but not as a contract manufacturer.  The problem I have with the definition of a foreign exporter is that it is any one that "offers for export to the United States (U.S.), a device manufactured.." so it is not clear if the foreign exporter is doing the manufacturing.  I am pushing back on the contract manufacturer that they need to add a registration as a contract manufacturer.  

I am curious what combination of registrations the group thinks is appropriate here.  If they register as a contract manufacturer do they need to also register as foreign exporter and vice versa?

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqasystems.com
------------------------------

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

Michelle, 

We received confirmation from FDA stating that an establishment can list as either a Foreign Exporter or a Contract Manufacturer, but wouldn't need to list both in any case. If the Exporter is also the Contract Manufacturer, then they would simply list as the contract manufacturer. An establishment would only register as the Foreign Exporter if that was their only role in the supply chain for the device. 

Thank you, everyone, for your feedback on the issue. I was talking about devices specifically in my initial question if that helps with context. 


------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

Original Message:
Sent: 04-Dec-2018 15:49
From: Michelle Lott
Subject: Who can be the Foreign Exporter according to FDA?

Hi Maddi
I have also recently had challenges in understanding what role is appropriate for a particular company's registration.  My client has a contract manufacturer that holds a registration as a foreign exporter but not as a contract manufacturer.  The problem I have with the definition of a foreign exporter is that it is any one that "offers for export to the United States (U.S.), a device manufactured.." so it is not clear if the foreign exporter is doing the manufacturing.  I am pushing back on the contract manufacturer that they need to add a registration as a contract manufacturer.

I am curious what combination of registrations the group thinks is appropriate here.  If they register as a contract manufacturer do they need to also register as foreign exporter and vice versa?

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqasystems.com

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 05-Dec-2018 12:59
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

Michelle,

We received confirmation from FDA stating that an establishment can list as either a Foreign Exporter or a Contract Manufacturer, but wouldn't need to list both in any case. If the Exporter is also the Contract Manufacturer, then they would simply list as the contract manufacturer. An establishment would only register as the Foreign Exporter if that was their only role in the supply chain for the device.

Thank you, everyone, for your feedback on the issue. I was talking about devices specifically in my initial question if that helps with context.


------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States

Original Message:
Sent: 04-Dec-2018 15:49
From: Michelle Lott
Subject: Who can be the Foreign Exporter according to FDA?

Hi Maddi
I have also recently had challenges in understanding what role is appropriate for a particular company's registration.  My client has a contract manufacturer that holds a registration as a foreign exporter but not as a contract manufacturer.  The problem I have with the definition of a foreign exporter is that it is any one that "offers for export to the United States (U.S.), a device manufactured.." so it is not clear if the foreign exporter is doing the manufacturing.  I am pushing back on the contract manufacturer that they need to add a registration as a contract manufacturer.

I am curious what combination of registrations the group thinks is appropriate here.  If they register as a contract manufacturer do they need to also register as foreign exporter and vice versa?

------------------------------
Michelle Lott RAC
Principal & Founder
michelle@leanraqasystems.com

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

​FDA's Device Advice Regulatory Assistance page has the following link (importing and exporting devices):

https://www.fda.gov/medicaldevices/deviceregulationandguidance/importingandexportingdevices/ucm050126.htm

Having had 30 years experience working for FDA, I have seen relatively innocuous importation issues escalate into potentially damaging regulatory consequences.  If the link above does not address your concerns, I would contact the Device Advice group directly and keep a record of your discussion(s), ideally via Email.  You could try to contact the FDA District Office that covers your port of entry, but in my experience those personnel may not respond in a timely manner.

------------------------------
Mark Lookabaugh
Principal Consultant
PAREXEL Consulting
United States
mark.lookabaugh@parexel.com
------------------------------

Original Message:
Sent: 03-Dec-2018 12:40
From: Maddi Myers
Subject: Who can be the Foreign Exporter according to FDA?

I'm aware of the FDA definition of a foreign exporter. However, the definition is vague in that it says the address must be outside the US. It does not say that the foreign exporter should be the last address before arriving in the US or anything like that. The current question is based on a product made and shipped to the US by a foreign contract manufacturer. Can the product owner/specification developer (who is in a different country) be listed as the foreign exporter? Or is the exact site of the product prior to shipping required to register as the foreign exporter?
Thank you for your time,

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------