Regulatory Open Forum

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Hi Bobbi,

21 CFR 801.45 includes the requirements for devices (i.e. reusable, reprocessed devices) that must be directly marked with a unique device identifier.  Exceptions are found under (d), which states that the requirement does not apply to any device that meets certain criteria, including (4) "The device has been previously marked under paragraph (a) of this section."  From this, it does not seem to be FDA's intention that a device must be directly marked with multiple UDIs from various manufacturers.  The situation you described may indeed be confusing for the user.

You didn't mention which issuing agency is associated with each UDI in question, but issuing agencies may provide guidance on how UDIs should be represented on products and labeling.  For example, the GS1 General Specifications includes the following:

Perhaps you could also consult with your issuing agency contact.

Thanks,




------------------------------
Camille Thorpe, RAC (Canada)
Toronto, ON
Canada
------------------------------

Original Message:
Sent: 12-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Hi Bobbi

It sounds like they are private labeling for you with  only your name on the product in the market.  Yours in the US and theirs in the EU?

If your name is on the device with labeling that says "Manufactured for XXXXX" and their name doesn't  appear on label...it really should just  have your UDI, in my opinion.   Sounds as if you are the legal manufacturer by name and  they are OEM.  Complaints should  be reported  to you(not both if labeled under your name), and you have the responsibility for reporting adverse events, recall actions, listings, etc.  (You of course need to communicate to them if you have complaints, MDRs, want to do a recall on your own labeled version and would have a Quality agreement  and Supply agreement in place?)

This just sounds like an inventory  management  issue for them and you where they make and mark your devices separately  from "their" labeled devices.


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

Original Message:
Sent: 13-May-2020 19:26
From: Camille Thorpe
Subject: Off Shelf Instrument

Hi Bobbi,

21 CFR 801.45 includes the requirements for devices (i.e. reusable, reprocessed devices) that must be directly marked with a unique device identifier.  Exceptions are found under (d), which states that the requirement does not apply to any device that meets certain criteria, including (4) "The device has been previously marked under paragraph (a) of this section."  From this, it does not seem to be FDA's intention that a device must be directly marked with multiple UDIs from various manufacturers.  The situation you described may indeed be confusing for the user.

You didn't mention which issuing agency is associated with each UDI in question, but issuing agencies may provide guidance on how UDIs should be represented on products and labeling.  For example, the GS1 General Specifications includes the following:

Perhaps you could also consult with your issuing agency contact.

Thanks,




------------------------------
Camille Thorpe, RAC (Canada)
Toronto, ON
Canada

Original Message:
Sent: 12-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Ginger, 

Yes that would be the case except they are not removing their direct part mark before adding ours so the part includes direct part mark with their name, part number, CE mark and UDI number and our name, part number and UDI number.  We do not have a CE mark approval for this part.  My concern is that the part is labeled with 2 different manufacturers information.

There would be no question if they were removing their information and adding ours just not comfortable with the part having both direct marked on it.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 14-May-2020 05:55
From: Ginger Cantor
Subject: Off Shelf Instrument

Hi Bobbi

It sounds like they are private labeling for you with  only your name on the product in the market.  Yours in the US and theirs in the EU?

If your name is on the device with labeling that says "Manufactured for XXXXX" and their name doesn't  appear on label...it really should just  have your UDI, in my opinion.   Sounds as if you are the legal manufacturer by name and  they are OEM.  Complaints should  be reported  to you(not both if labeled under your name), and you have the responsibility for reporting adverse events, recall actions, listings, etc.  (You of course need to communicate to them if you have complaints, MDRs, want to do a recall on your own labeled version and would have a Quality agreement  and Supply agreement in place?)

This just sounds like an inventory  management  issue for them and you where they make and mark your devices separately  from "their" labeled devices.

Am I missing something?

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

Original Message:
Sent: 13-May-2020 19:26
From: Camille Thorpe
Subject: Off Shelf Instrument

Hi Bobbi,

21 CFR 801.45 includes the requirements for devices (i.e. reusable, reprocessed devices) that must be directly marked with a unique device identifier.  Exceptions are found under (d), which states that the requirement does not apply to any device that meets certain criteria, including (4) "The device has been previously marked under paragraph (a) of this section."  From this, it does not seem to be FDA's intention that a device must be directly marked with multiple UDIs from various manufacturers.  The situation you described may indeed be confusing for the user.

You didn't mention which issuing agency is associated with each UDI in question, but issuing agencies may provide guidance on how UDIs should be represented on products and labeling.  For example, the GS1 General Specifications includes the following:

Perhaps you could also consult with your issuing agency contact.

Thanks,




------------------------------
Camille Thorpe, RAC (Canada)
Toronto, ON
Canada

Original Message:
Sent: 12-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Hi Bobbi

I think you need  to really request they only put your UDI on, to avoid confusion.  I am with you on this. 


Have you reached out to FDA DICE? I have found them helpful  in these types of situations.

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

Original Message:
Sent: 14-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Ginger,

Yes that would be the case except they are not removing their direct part mark before adding ours so the part includes direct part mark with their name, part number, CE mark and UDI number and our name, part number and UDI number.  We do not have a CE mark approval for this part.  My concern is that the part is labeled with 2 different manufacturers information.

There would be no question if they were removing their information and adding ours just not comfortable with the part having both direct marked on it.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States

Original Message:
Sent: 14-May-2020 05:55
From: Ginger Cantor
Subject: Off Shelf Instrument

Hi Bobbi

It sounds like they are private labeling for you with  only your name on the product in the market.  Yours in the US and theirs in the EU?

If your name is on the device with labeling that says "Manufactured for XXXXX" and their name doesn't  appear on label...it really should just  have your UDI, in my opinion.   Sounds as if you are the legal manufacturer by name and  they are OEM.  Complaints should  be reported  to you(not both if labeled under your name), and you have the responsibility for reporting adverse events, recall actions, listings, etc.  (You of course need to communicate to them if you have complaints, MDRs, want to do a recall on your own labeled version and would have a Quality agreement  and Supply agreement in place?)

This just sounds like an inventory  management  issue for them and you where they make and mark your devices separately  from "their" labeled devices.

Am I missing something?

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

Original Message:
Sent: 13-May-2020 19:26
From: Camille Thorpe
Subject: Off Shelf Instrument

Hi Bobbi,

21 CFR 801.45 includes the requirements for devices (i.e. reusable, reprocessed devices) that must be directly marked with a unique device identifier.  Exceptions are found under (d), which states that the requirement does not apply to any device that meets certain criteria, including (4) "The device has been previously marked under paragraph (a) of this section."  From this, it does not seem to be FDA's intention that a device must be directly marked with multiple UDIs from various manufacturers.  The situation you described may indeed be confusing for the user.

You didn't mention which issuing agency is associated with each UDI in question, but issuing agencies may provide guidance on how UDIs should be represented on products and labeling.  For example, the GS1 General Specifications includes the following:

Perhaps you could also consult with your issuing agency contact.

Thanks,




------------------------------
Camille Thorpe, RAC (Canada)
Toronto, ON
Canada

Original Message:
Sent: 12-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Camille, 

Thank you, I will definitely reach out to our issuing agency to see what advise they can provide.  We do use GS1 I am not sure who the manufacturer that makes the part uses.

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 13-May-2020 19:26
From: Camille Thorpe
Subject: Off Shelf Instrument

Hi Bobbi,

21 CFR 801.45 includes the requirements for devices (i.e. reusable, reprocessed devices) that must be directly marked with a unique device identifier.  Exceptions are found under (d), which states that the requirement does not apply to any device that meets certain criteria, including (4) "The device has been previously marked under paragraph (a) of this section."  From this, it does not seem to be FDA's intention that a device must be directly marked with multiple UDIs from various manufacturers.  The situation you described may indeed be confusing for the user.

You didn't mention which issuing agency is associated with each UDI in question, but issuing agencies may provide guidance on how UDIs should be represented on products and labeling.  For example, the GS1 General Specifications includes the following:

Perhaps you could also consult with your issuing agency contact.

Thanks,




------------------------------
Camille Thorpe, RAC (Canada)
Toronto, ON
Canada

Original Message:
Sent: 12-May-2020 09:33
From: Bobbi Siddoway
Subject: Off Shelf Instrument

Currently we purchase a few off the shelf reusable instruments (FDA Class I) that the manufacturer then direct part marks with our part number, UDI and logo to.  They are in the process of getting their MDR certificate and are going to add their UDI to the direct part marks, so the instrument would come to us with both manufacturers names, part numbers, and UDI numbers direct part marked on the instrument and I am assuming with a CE mark which we are not cleared for.  On the FDA side having both manufacturers information on the instrument seems to me like it would not be acceptable as the consumer would be confused by who to contact or put as the manufacturer for a complaint/issue.  Looking for others viewpoints and if there is somewhere in a regulation whether EU or FDA that I could use to show that this would not be acceptable.

Thank you,

------------------------------
Bobbi Siddoway
Regulatory/Document Control Specialist
Salt Lake City UT
United States
------------------------------