Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

You've done a nice job analyzing the issue thus far.  To round it out:

• Neither Company A nor Company B can be the Initial Importer due to the reason you state.
• Yes, checking if one of the US retailers or if Company B's Initial Importer is willing to so act regarding the subject device is a good option.  If none of those parties are willing to be (and so register as) the Initial Importer, then an alternative Initial Importer will need to be identified and registered.
• Company A also appears to meet the definition of 'Foreign Exporter'.
• To further avoid U.S. customs issues, also crucial is to be sure that the import brokering is done effectively so that the import entry filings for the shipment(s) properly reflect the FDA regulatory details for the subject device and associated stakeholders.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

One more thing,

All foreign manufacturers also need to designate a US Agent when they list the device, in addition to initial importer. If this is your initial  importer, fine, but there are two designations that are identified.  Be sure to look up the legal definitions for both. In 21 CFR 807.

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

Original Message:
Sent: 20-Nov-2020 13:35
From: Kevin Randall
Subject: FDA establishment registration: foreign private label distributor and initial importer

You've done a nice job analyzing the issue thus far.  To round it out:

• Neither Company A nor Company B can be the Initial Importer due to the reason you state.
• Yes, checking if one of the US retailers or if Company B's Initial Importer is willing to so act regarding the subject device is a good option.  If none of those parties are willing to be (and so register as) the Initial Importer, then an alternative Initial Importer will need to be identified and registered.
• Company A also appears to meet the definition of 'Foreign Exporter'.
• To further avoid U.S. customs issues, also crucial is to be sure that the import brokering is done effectively so that the import entry filings for the shipment(s) properly reflect the FDA regulatory details for the subject device and associated stakeholders.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

This message was posted by a user wishing to remain anonymous

Hi Ginger,
Thank you very much for your inputs.

Thankfully Company B has already appointed a US agent for their current site and activities (they've been manufacturing and selling their own similar products in the US for a while). At least this role is sorted!
Original Message:
Sent: 21-Nov-2020 08:01
From: Ginger Cantor
Subject: FDA establishment registration: foreign private label distributor and initial importer

One more thing,

All foreign manufacturers also need to designate a US Agent when they list the device, in addition to initial importer. If this is your initial  importer, fine, but there are two designations that are identified.  Be sure to look up the legal definitions for both. In 21 CFR 807.

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

Original Message:
Sent: 20-Nov-2020 13:35
From: Kevin Randall
Subject: FDA establishment registration: foreign private label distributor and initial importer

You've done a nice job analyzing the issue thus far.  To round it out:

• Neither Company A nor Company B can be the Initial Importer due to the reason you state.
• Yes, checking if one of the US retailers or if Company B's Initial Importer is willing to so act regarding the subject device is a good option.  If none of those parties are willing to be (and so register as) the Initial Importer, then an alternative Initial Importer will need to be identified and registered.
• Company A also appears to meet the definition of 'Foreign Exporter'.
• To further avoid U.S. customs issues, also crucial is to be sure that the import brokering is done effectively so that the import entry filings for the shipment(s) properly reflect the FDA regulatory details for the subject device and associated stakeholders.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

This message was posted by a user wishing to remain anonymous

Thank you very much, Kevin. I appreciate it. These things are always a bit of a puzzle! Regarding the 'Foreign Exporter' role, can you help me understand how/why it would apply to Company A? I thought that the 'Foreign Exporter' role was only for when a product sets foot in the USA but is intended for sale outside of the USA only (for export only?)
Original Message:
Sent: 20-Nov-2020 13:35
From: Kevin Randall
Subject: FDA establishment registration: foreign private label distributor and initial importer

You've done a nice job analyzing the issue thus far.  To round it out:

• Neither Company A nor Company B can be the Initial Importer due to the reason you state.
• Yes, checking if one of the US retailers or if Company B's Initial Importer is willing to so act regarding the subject device is a good option.  If none of those parties are willing to be (and so register as) the Initial Importer, then an alternative Initial Importer will need to be identified and registered.
• Company A also appears to meet the definition of 'Foreign Exporter'.
• To further avoid U.S. customs issues, also crucial is to be sure that the import brokering is done effectively so that the import entry filings for the shipment(s) properly reflect the FDA regulatory details for the subject device and associated stakeholders.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

You are correct: The Foreign Exporter registration requirement is intended for those foreign firms who export into the U.S. (i.e., into a foreign trade zone) and then re-export the device from that foreign trade zone without the device having entered U.S. commerce.  If Company A doesn't meet this criterion, then the Foreign Exporter requirement would not apply; apologies for any confusion on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 22-Nov-2020 23:03
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

Thank you very much, Kevin. I appreciate it. These things are always a bit of a puzzle! Regarding the 'Foreign Exporter' role, can you help me understand how/why it would apply to Company A? I thought that the 'Foreign Exporter' role was only for when a product sets foot in the USA but is intended for sale outside of the USA only (for export only?)
Original Message:
Sent: 20-Nov-2020 13:35
From: Kevin Randall
Subject: FDA establishment registration: foreign private label distributor and initial importer

You've done a nice job analyzing the issue thus far.  To round it out:

• Neither Company A nor Company B can be the Initial Importer due to the reason you state.
• Yes, checking if one of the US retailers or if Company B's Initial Importer is willing to so act regarding the subject device is a good option.  If none of those parties are willing to be (and so register as) the Initial Importer, then an alternative Initial Importer will need to be identified and registered.
• Company A also appears to meet the definition of 'Foreign Exporter'.
• To further avoid U.S. customs issues, also crucial is to be sure that the import brokering is done effectively so that the import entry filings for the shipment(s) properly reflect the FDA regulatory details for the subject device and associated stakeholders.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

Forgot to mention one other element:  If Company A is the one doing the final labeling that converts or finishes Company B's device to have Company A's private labeling, then such labeling is a manufacturing operation that would trigger the need for Company A to also register as a Contract Manufacturer or Relabeler.  The private label variant needs to be reflected in a Device Master Record (DMR).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards

This message was posted by a user wishing to remain anonymous

Hi Kevin,
In this particular case, Company B (OEM) will also be in charge of all labeling/packaging activities. Company A will simply provide the brand name, logo and address. Therefore, my conclusion is that 'Contract manufacturer', 'Specification Developer' and 'Relabeler' do not apply in this case.

Good point regarding the DMR. I will make sure this is included in the supplier agreement as well. Thank you!

Original Message:
Sent: 20-Nov-2020 13:50
From: Kevin Randall
Subject: FDA establishment registration: foreign private label distributor and initial importer

Forgot to mention one other element:  If Company A is the one doing the final labeling that converts or finishes Company B's device to have Company A's private labeling, then such labeling is a manufacturing operation that would trigger the need for Company A to also register as a Contract Manufacturer or Relabeler.  The private label variant needs to be reflected in a Device Master Record (DMR).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Nov-2020 19:47
From: Anonymous Member
Subject: FDA establishment registration: foreign private label distributor and initial importer

This message was posted by a user wishing to remain anonymous

I need some help with the initial importer role in the context of FDA establishment registration. Here's a summary of the situation:

A small Australian company (Company A) wants to sell a Class II, 510k exempt menstrual cup in the U.S. The product is designed and manufactured by an OEM (Company B) in China. Company B is already registered as a manufacturer with the FDA and has agreed to list (confidentially) Company A's product (with Company A's proprietary name). The product (menstrual cup) will be sold to US retailers and eventually direct to consumers with Company A's name and address on it. Company A will handle customer complaints.

My conclusion is that Company A needs to register as:

• Complaint File Establishment
• Foreign Private Label Distributor

Whereas Company B is simply registered as the manufacturer.

Both companies (A and B) will list Company's A proprietary name on their listing but only Company B will do it confidentially.

My question is with regards to the initial importer role. I originally thought that Company A could also be the initial importer but FDA's definition states that it needs to be a US-based company.

Is an initial importer required if Company A already registers as the Foreign Private Label Distributor? If yes and it can't be Company A because it is not in the US, my idea is to check if one of the US retailers or Company B's initial importer could act as the initial importer for Company A. What is the easiest/safest way to avoid hurdles for customs clearance? Do you have further recommendations?

Kind regards