Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Similarly, Regulation (EU) 2017/745, Annex I, point 23.2 does not require the CM to be identified on the label, and doesn't prohibit it, and doesn't require 'Made in Country XYZ'.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Thanks Anne for addressing the EU part of the question that I overlooked.  Agreed with Anne on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 05-Jul-2022 14:44
From: Anne LeBlanc
Subject: Stating a contract manufacturer name and address on labeling

Similarly, Regulation (EU) 2017/745, Annex I, point 23.2 does not require the CM to be identified on the label, and doesn't prohibit it, and doesn't require 'Made in Country XYZ'.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Forgot to mention that for Europe's Regulation 2017/745:  If the contract manufacturer is named on the label with no other person(s) named and characterized thereon, then the contract manufacturer by default becomes the "manufacturer" responsible for 2017/745's obligations that apply to the "manufacturer" [e.g., for the technical documentation, declaration of conformity, risk management, quality management system, product certifications (where applicable), field safety corrective actions, serious incident reporting, and so on and so forth.].  Consequently, the contract manufacturer is usually not identified on the label for the European jurisdiction.

This is different than in the U.S. where, even if the CM is the only one named on the label, the specification developer nonetheless as a general rule remains the most responsible party obligated to assure conformity with FDA's various requirements (e.g., for premarket authorizations, corrective actions, recalls, control over the CM, etc.).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 05-Jul-2022 15:12
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Thanks Anne for addressing the EU part of the question that I overlooked.  Agreed with Anne on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Jul-2022 14:44
From: Anne LeBlanc
Subject: Stating a contract manufacturer name and address on labeling

Similarly, Regulation (EU) 2017/745, Annex I, point 23.2 does not require the CM to be identified on the label, and doesn't prohibit it, and doesn't require 'Made in Country XYZ'.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

This message was posted by a user wishing to remain anonymous

Thank you Kevin and Anne.

In addition, CM has to register, list and pay the fee (FDA).


Original Message:
Sent: 05-Jul-2022 15:25
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Forgot to mention that for Europe's Regulation 2017/745:  If the contract manufacturer is named on the label with no other person(s) named and characterized thereon, then the contract manufacturer by default becomes the "manufacturer" responsible for 2017/745's obligations that apply to the "manufacturer" [e.g., for the technical documentation, declaration of conformity, risk management, quality management system, product certifications (where applicable), field safety corrective actions, serious incident reporting, and so on and so forth.].  Consequently, the contract manufacturer is usually not identified on the label for the European jurisdiction.

This is different than in the U.S. where, even if the CM is the only one named on the label, the specification developer nonetheless as a general rule remains the most responsible party obligated to assure conformity with FDA's various requirements (e.g., for premarket authorizations, corrective actions, recalls, control over the CM, etc.).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Jul-2022 15:12
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Thanks Anne for addressing the EU part of the question that I overlooked.  Agreed with Anne on that.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 05-Jul-2022 14:44
From: Anne LeBlanc
Subject: Stating a contract manufacturer name and address on labeling

Similarly, Regulation (EU) 2017/745, Annex I, point 23.2 does not require the CM to be identified on the label, and doesn't prohibit it, and doesn't require 'Made in Country XYZ'.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

As a note to the conversation, foreign manufactured finished products (including product to be repackaged) must include on a label the "country of origin" (Customs Regulations, 19 CFR Part 177). This is not an FDA requirement.

There some exclusion and some additional requirement for medical instruments.

• • Knives, forks, steels 
  • Cleavers, clippers, shears 
  • Scissors, safety razors, blades for safety razors 
  • Surgical instruments, dental instruments 
  • Scientific and laboratory instruments 
  • Pliers, pincers, nippers and hinged hand-tools for holding and splicing wire Vacuum containers and parts of the above articles 

If you are importing, you should have an Importers Manual with procedures to manage the activities.

Bob Bard

------------------------------
Robert J. Bard, JD, RAC CQE
Managing Director
HealthCare Technologies Consultants, LLC
Northville, MI
USA
------------------------------

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Many thanks Robert for mentioning those additional trade/customs items that are outside the scope of FDA's medical device labeling regulations.  After a brief review of 19 CFR Part 177, I was unable to locate requirements stating that foreign manufactured finished products (including product to be repackaged) must include on a label the "country of origin".  Wondering if you might be able to point us to the Part 177 section that requires this.  Thanks in advance for your help. 

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Jul-2022 10:05
From: Robert Bard
Subject: Stating a contract manufacturer name and address on labeling

As a note to the conversation, foreign manufactured finished products (including product to be repackaged) must include on a label the "country of origin" (Customs Regulations, 19 CFR Part 177). This is not an FDA requirement.

There some exclusion and some additional requirement for medical instruments.

Special Markings on Certain Articles 
The following articles and parts thereof, unless otherwise subject to the marking exceptions provided for in 19 U.S.C. 1304, must be marked legibly and conspicuously with their country of origin by die-stamping, cast-in-mold lettering, etching (acid or electrolytic), engraving, or by means of metal plates which bear the prescribed marking and which are securely attached to the article in a conspicuous place by welding, screws, or rivets: 

• • Knives, forks, steels 
  • Cleavers, clippers, shears 
  • Scissors, safety razors, blades for safety razors 
  • Surgical instruments, dental instruments 
  • Scientific and laboratory instruments 
  • Pliers, pincers, nippers and hinged hand-tools for holding and splicing wire Vacuum containers and parts of the above articles 

If you are importing, you should have an Importers Manual with procedures to manage the activities.

Bob Bard

------------------------------
Robert J. Bard, JD, RAC CQE
Managing Director
HealthCare Technologies Consultants, LLC
Northville, MI
USA

Original Message:
Sent: 05-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Many thanks as always Ginger for your great insights, this time regarding the trade laws that are outside the scope of FDA's medical device labeling regulations for contract manufacturer identification.  Looking forward to Robert's (or your) additional guidance pointing us to the applicable regulations regarding general product labeling of the country of origin.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Jul-2022 11:42
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Hi Kevin

I will have to look that up if not CFR 19.  When I was  at 3M, each RA had to break down everything with our corporate Trade Office to be accurate in labelling.  A huge project!

So, you learn a bit more in every job.   

;)

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

Original Message:
Sent: 06-Jul-2022 12:09
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Many thanks as always Ginger for your great insights, this time regarding the trade laws that are outside the scope of FDA's medical device labeling regulations for contract manufacturer identification.  Looking forward to Robert's (or your) additional guidance pointing us to the applicable regulations regarding general product labeling of the country of origin.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 11:42
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

EU briefing on country of origin labeling (not required):

https://www.europarl.europa.eu/RegData/bibliotheque/briefing/2013/130513/LDM_BRI%282013%29130513_REV1_EN.pdf

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 06-Jul-2022 12:28
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

Hi Kevin

I will have to look that up if not CFR 19.  When I was  at 3M, each RA had to break down everything with our corporate Trade Office to be accurate in labelling.  A huge project!

So, you learn a bit more in every job.

;)

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

Original Message:
Sent: 06-Jul-2022 12:09
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Many thanks as always Ginger for your great insights, this time regarding the trade laws that are outside the scope of FDA's medical device labeling regulations for contract manufacturer identification.  Looking forward to Robert's (or your) additional guidance pointing us to the applicable regulations regarding general product labeling of the country of origin.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 11:42
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

For the US, consider 19 CFR 134 (per 19 U.S.C. § 1304).

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 06-Jul-2022 16:06
From: Anne LeBlanc
Subject: Stating a contract manufacturer name and address on labeling

EU briefing on country of origin labeling (not required):

https://www.europarl.europa.eu/RegData/bibliotheque/briefing/2013/130513/LDM_BRI%282013%29130513_REV1_EN.pdf

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 06-Jul-2022 12:28
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

Hi Kevin

I will have to look that up if not CFR 19.  When I was  at 3M, each RA had to break down everything with our corporate Trade Office to be accurate in labelling.  A huge project!

So, you learn a bit more in every job.

;)

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

Original Message:
Sent: 06-Jul-2022 12:09
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Many thanks as always Ginger for your great insights, this time regarding the trade laws that are outside the scope of FDA's medical device labeling regulations for contract manufacturer identification.  Looking forward to Robert's (or your) additional guidance pointing us to the applicable regulations regarding general product labeling of the country of origin.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 11:42
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.

Hi Ginger.  Sounds great!  I look forward as always to your additional insights (or any additional insights that Robert can provide).  My personal experience over the years is that the "country of origin" labeling issue has often seemed nebulous.  That said, I'm not a customs/trade expert and have only dealt with customs/trade issues when absolutely needed during medical device import holds, none of which in my cases involved objections regarding country of origin labeling.  This is a great discussion.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Jul-2022 12:28
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

Hi Kevin

I will have to look that up if not CFR 19.  When I was  at 3M, each RA had to break down everything with our corporate Trade Office to be accurate in labelling.  A huge project!

So, you learn a bit more in every job.

;)

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

Original Message:
Sent: 06-Jul-2022 12:09
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

Many thanks as always Ginger for your great insights, this time regarding the trade laws that are outside the scope of FDA's medical device labeling regulations for contract manufacturer identification.  Looking forward to Robert's (or your) additional guidance pointing us to the applicable regulations regarding general product labeling of the country of origin.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Jul-2022 11:42
From: Ginger Cantor
Subject: Stating a contract manufacturer name and address on labeling

I agree with Kevin on name of CM not being required.  However, the Country of Origin is required under trade laws to apply tariffs, etc., and is based on the value of  materials and labor abd substantial transformation into the device.

You should decide this with your analysis of value added and supply chain, but it needs to be on the container.

------------------------------
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-Jul-2022 12:18
From: Kevin Randall
Subject: Stating a contract manufacturer name and address on labeling

The governing regulation for this topic is located at 21 CFR 801.1(c). That regulation does not require the CM to be identified on the label, yet doesn't prohibit it either.  That regulation also doesn't require 'Made in Country XYZ'.  Instead, that regulation is more flexible in requiring that if a device is not manufactured (i.e., fabricated, e.g., contract manufactured) by the person whose name appears on the label, then the name shall be qualified by a phrase that reveals the connection such person has with such device; like, "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts.

I've found that for various reasons (e.g., proprietary/trade secrets; logistics of complaint handling, etc.), most specification developers (i.e., firms who perform no fabrication and instead have the device made to their specifications by a CM) elect not to identify the CM on the label, instead employing the aforesaid flexibility offered by 21 CFR 801.1(c) which allows that only the specification developer be identified on the label.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jul-2022 21:38
From: Anonymous Member
Subject: Stating a contract manufacturer name and address on labeling

This message was posted by a user wishing to remain anonymous

Dear All,

If the contract manufacturer of a finished medical device is based outside of the legal manufacturer's country, is the legal manufacturer required to state the CM's name & address on the labeling (packaging, IFU), with respect to FDA and the EU requirements?

ie, something like:
Made in Country XYZ
CM name
CM address

Thank you.