Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work at a US device company and we use distributors internationally. They do not manufacture or design anything, they only distribute. But they may have to send product back to us in the US as a result of returns or complaints. Do these foreign distributors have to register with the FDA as a foreign exporter for returned product? Any guidance would be greatly appreciated. Thank you!

Tricky question as seems to be indicated by not having any answers yet.  I'll stick my neck out and give you a few of my thoughts.

As I understand it, FDA establishment registration may be required for a foreign distributor who is simply returning a device back to the U.S. manufacturer. This interpretation comes from FDA's definition of 'foreign exporter' (see FDA's establishment registration guidance web page; I don't recall an official definition of this term in Part 807 or its preamble) which incorporates devices originally manufactured in the United States.

If such registration actually is required (which seems to be overkill and nonsensical at first glance if the foreign distributor isn't actually intending to introduce the device into U.S. commercial distribution), then my guess is that it is due to the Bioterrorism Act that spurned FDA to increase controls over foreign establishments sending devices into the U.S.  Specifically, in response to the Bioterrorism Act and promulgation of corresponding revised Part 807 back in 2012, it appears that FDA may have taken a very sweeping stance that the mere action of foreign exportation is considered to be manufacture, preparation, propagation, compounding, or processing of a device, and thus triggers the registration requirement. FDA plainly said that § 807.40(c) prohibits a device from being imported or offered for import into the United States unless it is the subject of a device listing and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment (compliant Part 812 investigational use devices excepted per 807). FDA also plainly said that a device may not enter the country unless valid registration and listing information are provided. FDA says this information is used, for example, by verifying that medical devices entering the United States are exported from legitimate sources, are not counterfeit, and are legally marketed in the U.S.

On the other hand, if a device is being returned in specific correspondence with the manufacturer under proper returned goods authorization procedures of the manufacturer's quality system, then it would seem that the aforesaid FDA import controls placed on foreign exporters wouldn't be needed to assure protection against bioterrorism since the fundamental safeguards intended by FDA for such units may already be satisfied by the controls of the manufacturer's returned goods control process.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 09-Oct-2023 11:57
From: Anonymous Member
Subject: FDA Establishment Registration required for Foreign Distributors?

This message was posted by a user wishing to remain anonymous

I work at a US device company and we use distributors internationally. They do not manufacture or design anything, they only distribute. But they may have to send product back to us in the US as a result of returns or complaints. Do these foreign distributors have to register with the FDA as a foreign exporter for returned product? Any guidance would be greatly appreciated. Thank you!

Hello Anon,

If you read the definition on the FDA's website for foreign establishment registration - a Foreign Exporter is more an entity who is doing further processing or manufacturing.  Traditionally, if a distributor is returning goods due to complaints or servicing, this would typically not fall under the registration requirements.  Because the medical device should already be registered, there would then be a Returns Authorisation or like an RMA/RA assigned.  Then when the product comes back through customs/border control it is identified as a return.  Returning goods then is more part of import/export ensuring product is proper and able to be brought into the U.S.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Oct-2023 09:49
From: Kevin Randall
Subject: FDA Establishment Registration required for Foreign Distributors?

Tricky question as seems to be indicated by not having any answers yet.  I'll stick my neck out and give you a few of my thoughts.

As I understand it, FDA establishment registration may be required for a foreign distributor who is simply returning a device back to the U.S. manufacturer. This interpretation comes from FDA's definition of 'foreign exporter' (see FDA's establishment registration guidance web page; I don't recall an official definition of this term in Part 807 or its preamble) which incorporates devices originally manufactured in the United States.

If such registration actually is required (which seems to be overkill and nonsensical at first glance if the foreign distributor isn't actually intending to introduce the device into U.S. commercial distribution), then my guess is that it is due to the Bioterrorism Act that spurned FDA to increase controls over foreign establishments sending devices into the U.S.  Specifically, in response to the Bioterrorism Act and promulgation of corresponding revised Part 807 back in 2012, it appears that FDA may have taken a very sweeping stance that the mere action of foreign exportation is considered to be manufacture, preparation, propagation, compounding, or processing of a device, and thus triggers the registration requirement. FDA plainly said that § 807.40(c) prohibits a device from being imported or offered for import into the United States unless it is the subject of a device listing and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment (compliant Part 812 investigational use devices excepted per 807). FDA also plainly said that a device may not enter the country unless valid registration and listing information are provided. FDA says this information is used, for example, by verifying that medical devices entering the United States are exported from legitimate sources, are not counterfeit, and are legally marketed in the U.S.

On the other hand, if a device is being returned in specific correspondence with the manufacturer under proper returned goods authorization procedures of the manufacturer's quality system, then it would seem that the aforesaid FDA import controls placed on foreign exporters wouldn't be needed to assure protection against bioterrorism since the fundamental safeguards intended by FDA for such units may already be satisfied by the controls of the manufacturer's returned goods control process.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 09-Oct-2023 11:57
From: Anonymous Member
Subject: FDA Establishment Registration required for Foreign Distributors?

This message was posted by a user wishing to remain anonymous

I work at a US device company and we use distributors internationally. They do not manufacture or design anything, they only distribute. But they may have to send product back to us in the US as a result of returns or complaints. Do these foreign distributors have to register with the FDA as a foreign exporter for returned product? Any guidance would be greatly appreciated. Thank you!