Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

My company is based in the United States and establishment is registered with the FDA. We have several foreign affiliates that we would like to sell their products in the United States, but their establishments aren't registered with the FDA. After reading § 807.20, and seeing "except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments" does that mean my company in the United States can list the foreign affiliates products on our establishment and device listing with the FDA? 

Hello Anon,

it depends on how these Affiliates are set-up with the main company and more importantly how you are going to identify them within the marketing and selling in the United States.  One way is the company in the United States is registered as the Owner/Operator.  Then each foreign affiliate would have their establishment registered under the Owner/Operator depending on their activity, e.g. Specification Developer or Manufacturer.  Another way is the company in the United States is registered as the Owner/Operator.  The same facility is then registered as the Manufacturer for all of the products from the foreign facilities.  The foreign affiliates would then each register to again their function like Specification Developer, but would not register as Manufacturer, but as a Contract Manufacturer.  In this second instance, they would have their own registrations.  In some case, you might not want to register the foreign facility, depending on what they do.  The reason I say this is because in the two scenarios listed above, each facility would need an establishment registration which is $6,000+ USD ... every year.  The answer to your question is yes, but you may want to delve further into this because it can be more complicated based on what each foreign entity does, if they should be registered, and how the registration would be done.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 09-Nov-2023 20:58
From: Anonymous Member
Subject: FDA Establishment Registration & Affiliates

This message was posted by a user wishing to remain anonymous

Hello,

My company is based in the United States and establishment is registered with the FDA. We have several foreign affiliates that we would like to sell their products in the United States, but their establishments aren't registered with the FDA. After reading § 807.20, and seeing "except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments" does that mean my company in the United States can list the foreign affiliates products on our establishment and device listing with the FDA? 

This message was posted by a user wishing to remain anonymous

Not exactly. You have to list all the establishments, though you can show them as being under one owner/operator. Then you have to show which products belong to which establishments.

If they're managed separately, so you need to register them separately, they can still delegate you to help with the actual data entry.

Either way, they'll have to follow US regulations, and be subject to inspections.

Original Message:
Sent: 09-Nov-2023 20:58
From: Anonymous Member
Subject: FDA Establishment Registration & Affiliates

This message was posted by a user wishing to remain anonymous

Hello,

My company is based in the United States and establishment is registered with the FDA. We have several foreign affiliates that we would like to sell their products in the United States, but their establishments aren't registered with the FDA. After reading § 807.20, and seeing "except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments" does that mean my company in the United States can list the foreign affiliates products on our establishment and device listing with the FDA?