Regulatory Open Forum

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.

In the development of the US UDI regulation, we "borrowed" the concept of "labeler" (as the responsible party) from CDER (NDCs) because "manufacturer" had too many meanings.  It was simply meant to recognize, and allow, the many different private labeling situations that occur in the US [by contrast, the EU MDR/IVDR certainly changes this conversation].  If the device is being commercialized as "your" device - then it is your device - and your UDI, etc,  In the US, it does not matter, for purposes of UDI, who physically manufacturers the device, who owns the 510k, etc.  Certainly, R&L needs to accurately reflect the roles and responsibilities of the various players.  But, private labeling occurs in all sectors of our space -  and the notion of responsible party for UDI should be straightforward.

------------------------------
Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States

Original Message:
Sent: 25-May-2023 06:07
From: Anonymous Member
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

This message was posted by a user wishing to remain anonymous

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.

Some other thoughts for consideration:

In the U.S., a "private labeler" is generally viewed and handled as a wholesale distributor who is simply marketing a version of a registered OEM manufacturer's device where such device has been labeled/branded by, and/or under license/authorization from, the registered OEM manufacturer.  In this common scenario, the private label distributor (wholesale distributor) is exempt from FDA registration and device listing (unless a foreign entity), and the private-label version of the OEM manufacturer's device is managed and listed and UDI labeled under the covering of the OEM manufacturer's FDA registration and quality system.

That remains the case even if the OEM manufacturer uses a contract manufacturer to fabricate/label the device.  In a contract manufacturing scenario, I still consider the OEM to be the one "causing" the label to be applied, not the wholesale distributor, though the implementation is being outsourced. In guidance, FDA gave an interpretive paraphrase of "Labeler" which I find insightful: "The labeler is responsible for compliance with the UDI requirements."

The wholesale distributor category has traditionally allowed, and the UDI regulation echoes, that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label doesn't exceed the aforesaid wholesale distributor exemption threshold, nor the UDI "labeler" threshold.  FDA has traditionally given the example of where a distributor simply places a "sticker" on the OEM's product to identify the distributor without obscuring or altering the OEM's regulated label/labeling.  FDA reiterates this in UDI guidance for the UDI context.

That said, FDA also reminds us that a private label distributor might sometimes trigger the UDI labeler threshold.  To help delineate such scenarios, we need to rely on FDA's overarching controls for manufacturers.  Specifically, if the wholesale distributor acts independent of the OEM and is doing the private labeling independent of the OEM, then that makes the wholesale distributor into a manufacturer who then has its own independent FDA registration, quality system, and UDI labeling obligations.  Indeed, when promulgating the UDI regulations, FDA said that, in most instances, the labeler would be the device manufacturer, yet that the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler (these are various types of manufacturing operations).  But again, if the distributor is simply adding its name and contact information without obscuring the OEM's regulated labeling, then such distributor hasn't become a manufacturer or UDI labeler.

Accordingly, as long as the private labeler stays under FDA's "wholesale distributor" categorization, then it need not bother with the obligations of a UDI Labeler, as that will already be covered by the OEM even for the private label versions of the OEM's devices being marketed by "private labelers" (i.e., authorized wholesale distributors).

------------------------------
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: 07-Jun-2023 00:46
From: Jay Crowley
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

In the development of the US UDI regulation, we "borrowed" the concept of "labeler" (as the responsible party) from CDER (NDCs) because "manufacturer" had too many meanings.  It was simply meant to recognize, and allow, the many different private labeling situations that occur in the US [by contrast, the EU MDR/IVDR certainly changes this conversation].  If the device is being commercialized as "your" device - then it is your device - and your UDI, etc,  In the US, it does not matter, for purposes of UDI, who physically manufacturers the device, who owns the 510k, etc.  Certainly, R&L needs to accurately reflect the roles and responsibilities of the various players.  But, private labeling occurs in all sectors of our space -  and the notion of responsible party for UDI should be straightforward.

------------------------------
Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States

Original Message:
Sent: 25-May-2023 06:07
From: Anonymous Member
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

This message was posted by a user wishing to remain anonymous

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.

Well...I'd originally tried not to get into too much depth about what is a "private labeler".  But offline I received a comment expressing concern that my prior post may be confusing or incorrect with respect to the definition of "private labeling".  So, let's dive deeper on that to be sure I've been clear.

The first paragraph of my preceding post was intended to convey that a private labeled device is (as the offline comment more directly stated), "...being sold as that private labeler's [own] device." [emphasis added].  My apologies if that wasn't clear from my prior post.  In other words, private labeling means that the device bears the private labeler's own name (meaning company name and/or brand name; I explain that further below) and contact information, rather than the OEM's.

As a related aside, I can think of two "official" places in FDA device regulations that address private labeling.  Specifically, those are 21 CFR 807.65(e) and also in the original Medical Device Reporting Part 803 preamble at 49 FR 36335 [where FDA echoes the intent of 807.65(e) and refers to a private label distributor as, "...a distributor that obtains a device from a manufacturer with the label already applied and that does not repackage or otherwise alter the device's package or label…"] [emphasis added].  I've also had FDA's DICE (at the time DSMICA) reiterate this explanation of private labelers and also confirm that it was "verified for accuracy by the appropriate CDRH Office or other FDA component".

Pursuant to 807.65(e), private label arrangements are generally considered by FDA to be wholesale or other distribution that is exempt from registration, listing, and quality system requirements (except for complaint handling), consequently meaning that such a private labeled device remains under the regulatory responsibility of the OEM.  For example, FDA's DICE (at the time DSMICA) reiterated this to me, along with clarification that the exempt distributor categorization remains for the private labelers when the OEM makes or authorizes the private labeled version for the private labeler (i.e., the private labeler doesn't do or arrange for the relabeling autonomously from the OEM).  Below, I've posted a link to an interesting article from a different author who also mentions this same kind of interpretation.

In other words, as I mentioned in my first post, the distributor exemptions may go away if the private labeling is being done by or for the private labeler autonomously from the OEM (i.e., without the OEM's knowledge/authorization, in which case the private labeler becomes the UDI labeler).

This background is important and governing because, while true that FDA "borrowed" the UDI "labeler" concept from the drug side, FDA apparently didn't realize the device regulatory contravention and confusion it would cause in the device space.  For a perspective on this, see this article.  Indeed, the broadness FDA envisioned and has tried to practice regarding the UDI "labeler" concept creates a regulatory contravention with the aforesaid Part 807 regulatory exemptions for private labelers.  Specifically, it is nonsensical and conflicts with governing FDA regulations [e.g., 807.65(e)] if FDA considers a private labeler to be the UDI labeler.  Why?  Because private labelers are exempt from GMP, establishment registration, and device listing and those are intrinsically needed for FDA enforcement of UDI compliance.

Accordingly, I would caution stakeholders against asserting that the UDI regulation and its definition of "labeler" somehow trump or undo the fundamental regulatory exemptions for private labelers in Part 807.  Instead, my understanding is that FDA wanted the UDI labeler concept to be flexible enough to allow firms wide logistical liberty for fulfilling the UDI requirements via various business models.  I don't believe it was FDA's intent for the UDI labeler obligations to be dictated by the chosen business model.  The aforesaid article gives additional supporting evidence for this interpretation.

Again, a bottom line is that, if a "private labeler" is doing so under the covering of the OEM's registration, device listings, quality system, 510(k), etc., then the OEM is the one who causes the label to be applied; consequently, the OEM is the UDI labeler in that scenario.  But if the "private labeler" is instead doing so autonomously from the OEM, then that's where the private labeler would generally exceed the Part 807 distributor exemptions and thus becomes a type of manufacturer and thus the one responsible for UDI compliance.  This is deeply influenced by FDA's statutory approach to "manufacture", which I won't delve into here unless requested to do so. 

Finally, the offline comment I received also seemed to assert that private labeling does NOT include the addition of the name of, and contact information for, a person who distributes the device. I presume that this offline assertion was triggered by the third paragraph of my preceding post where I generally implied that the opposite could be true. In other words, the offline comment I received seems to be saying that private labelers are not encompassed by FDA's UDI guidance statements like, "Distributors who only place their name and contact information on the label without changing the label any further are not considered [UDI] labelers". [emphasis added].

My interpretation differs from that offline assertion.  Specifically, regardless of whether a distributor simply adds a sticker with its company name and contact information to an OEM named/branded device, or if instead the private labeler has OEM authorization to market the OEM's device disguised as the private labeler's device (notwithstanding the required "Manufactured for" or "Distributed by" clarifier), either scenario may be encompassed by the UDI regulation labeler exclusion wording, "...except that the addition of the name of, and contact information for, a person who distributes the device...is not…a labeler" [emphasis added]. This is because either scenario is governed by the aforesaid Part 807 distributor exemptions [807.65(e) and 807.20(c)].  Accordingly, I don't believe that there is valid regulatory premise to declare that a private labeler must be the UDI labeler (unless it does so autonomously from the OEM).  For example, FDA investigators are instructed and mandated that if a "relabeler" distributes the device under its own name (thus becoming a private labeler) without otherwise changing the OEM's labeling, then the 807.65(e) and 807.20(c) exemptions apply.

------------------------------
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: 07-Jun-2023 16:15
From: Kevin Randall
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

Some other thoughts for consideration:

In the U.S., a "private labeler" is generally viewed and handled as a wholesale distributor who is simply marketing a version of a registered OEM manufacturer's device where such device has been labeled/branded by, and/or under license/authorization from, the registered OEM manufacturer.  In this common scenario, the private label distributor (wholesale distributor) is exempt from FDA registration and device listing (unless a foreign entity), and the private-label version of the OEM manufacturer's device is managed and listed and UDI labeled under the covering of the OEM manufacturer's FDA registration and quality system.

That remains the case even if the OEM manufacturer uses a contract manufacturer to fabricate/label the device.  In a contract manufacturing scenario, I still consider the OEM to be the one "causing" the label to be applied, not the wholesale distributor, though the implementation is being outsourced. In guidance, FDA gave an interpretive paraphrase of "Labeler" which I find insightful: "The labeler is responsible for compliance with the UDI requirements."

The wholesale distributor category has traditionally allowed, and the UDI regulation echoes, that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label doesn't exceed the aforesaid wholesale distributor exemption threshold, nor the UDI "labeler" threshold.  FDA has traditionally given the example of where a distributor simply places a "sticker" on the OEM's product to identify the distributor without obscuring or altering the OEM's regulated label/labeling.  FDA reiterates this in UDI guidance for the UDI context.

That said, FDA also reminds us that a private label distributor might sometimes trigger the UDI labeler threshold.  To help delineate such scenarios, we need to rely on FDA's overarching controls for manufacturers.  Specifically, if the wholesale distributor acts independent of the OEM and is doing the private labeling independent of the OEM, then that makes the wholesale distributor into a manufacturer who then has its own independent FDA registration, quality system, and UDI labeling obligations.  Indeed, when promulgating the UDI regulations, FDA said that, in most instances, the labeler would be the device manufacturer, yet that the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler (these are various types of manufacturing operations).  But again, if the distributor is simply adding its name and contact information without obscuring the OEM's regulated labeling, then such distributor hasn't become a manufacturer or UDI labeler.

Accordingly, as long as the private labeler stays under FDA's "wholesale distributor" categorization, then it need not bother with the obligations of a UDI Labeler, as that will already be covered by the OEM even for the private label versions of the OEM's devices being marketed by "private labelers" (i.e., authorized wholesale distributors).

------------------------------
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: 07-Jun-2023 00:46
From: Jay Crowley
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

In the development of the US UDI regulation, we "borrowed" the concept of "labeler" (as the responsible party) from CDER (NDCs) because "manufacturer" had too many meanings.  It was simply meant to recognize, and allow, the many different private labeling situations that occur in the US [by contrast, the EU MDR/IVDR certainly changes this conversation].  If the device is being commercialized as "your" device - then it is your device - and your UDI, etc,  In the US, it does not matter, for purposes of UDI, who physically manufacturers the device, who owns the 510k, etc.  Certainly, R&L needs to accurately reflect the roles and responsibilities of the various players.  But, private labeling occurs in all sectors of our space -  and the notion of responsible party for UDI should be straightforward.

------------------------------
Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States

Original Message:
Sent: 25-May-2023 06:07
From: Anonymous Member
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

This message was posted by a user wishing to remain anonymous

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.

Kevin - sorry, but I feel that this thread continues to confuse activities of a distributor with that of a company placing a device on the market under its own name/brand (aka, a private labeled device).  Private labeling exists in other sectors - especially the drug space - and it was from there that we "borrowed" the concept of labeler for purposes of the UDI regulation.  If a company is having a device "labeled" for them (e.g., having their trade name, brand name placed on the label) - then they are the labeler of the device and are responsible for the UDI of that device, including its GUDID submission (under their name).

I talked a lot about this during the development of the UDI regulation and after its final publication - and was hoping that we put this behind us.  I encourage anyone with questions to reach out to me directly - I am happy to discuss further.  Alternatively, I suggest looking at products from other industries (e.g., drugs, consumer products) - and you will see that the identification of the product belongs (is the responsibility of and points) to, to borrow a GS1 term, the "brand owner" of the device.

Thanks - Jay

Well...I'd originally tried not to get into too much depth about what is a "private labeler".  But offline I received a comment expressing concern that my prior post may be confusing or incorrect with respect to the definition of "private labeling".  So, let's dive deeper on that to be sure I've been clear.

The first paragraph of my preceding post was intended to convey that a private labeled device is (as the offline comment more directly stated), "...being sold as that private labeler's [own] device." [emphasis added].  My apologies if that wasn't clear from my prior post.  In other words, private labeling means that the device bears the private labeler's own name (meaning company name and/or brand name; I explain that further below) and contact information, rather than the OEM's.

As a related aside, I can think of two "official" places in FDA device regulations that address private labeling.  Specifically, those are 21 CFR 807.65(e) and also in the original Medical Device Reporting Part 803 preamble at 49 FR 36335 [where FDA echoes the intent of 807.65(e) and refers to a private label distributor as, "...a distributor that obtains a device from a manufacturer with the label already applied and that does not repackage or otherwise alter the device's package or label…"] [emphasis added].  I've also had FDA's DICE (at the time DSMICA) reiterate this explanation of private labelers and also confirm that it was "verified for accuracy by the appropriate CDRH Office or other FDA component".

Pursuant to 807.65(e), private label arrangements are generally considered by FDA to be wholesale or other distribution that is exempt from registration, listing, and quality system requirements (except for complaint handling), consequently meaning that such a private labeled device remains under the regulatory responsibility of the OEM.  For example, FDA's DICE (at the time DSMICA) reiterated this to me, along with clarification that the exempt distributor categorization remains for the private labelers when the OEM makes or authorizes the private labeled version for the private labeler (i.e., the private labeler doesn't do or arrange for the relabeling autonomously from the OEM).  Below, I've posted a link to an interesting article from a different author who also mentions this same kind of interpretation.

In other words, as I mentioned in my first post, the distributor exemptions may go away if the private labeling is being done by or for the private labeler autonomously from the OEM (i.e., without the OEM's knowledge/authorization, in which case the private labeler becomes the UDI labeler).

This background is important and governing because, while true that FDA "borrowed" the UDI "labeler" concept from the drug side, FDA apparently didn't realize the device regulatory contravention and confusion it would cause in the device space.  For a perspective on this, see this article.  Indeed, the broadness FDA envisioned and has tried to practice regarding the UDI "labeler" concept creates a regulatory contravention with the aforesaid Part 807 regulatory exemptions for private labelers.  Specifically, it is nonsensical and conflicts with governing FDA regulations [e.g., 807.65(e)] if FDA considers a private labeler to be the UDI labeler.  Why?  Because private labelers are exempt from GMP, establishment registration, and device listing and those are intrinsically needed for FDA enforcement of UDI compliance.

Accordingly, I would caution stakeholders against asserting that the UDI regulation and its definition of "labeler" somehow trump or undo the fundamental regulatory exemptions for private labelers in Part 807.  Instead, my understanding is that FDA wanted the UDI labeler concept to be flexible enough to allow firms wide logistical liberty for fulfilling the UDI requirements via various business models.  I don't believe it was FDA's intent for the UDI labeler obligations to be dictated by the chosen business model.  The aforesaid article gives additional supporting evidence for this interpretation.

Again, a bottom line is that, if a "private labeler" is doing so under the covering of the OEM's registration, device listings, quality system, 510(k), etc., then the OEM is the one who causes the label to be applied; consequently, the OEM is the UDI labeler in that scenario.  But if the "private labeler" is instead doing so autonomously from the OEM, then that's where the private labeler would generally exceed the Part 807 distributor exemptions and thus becomes a type of manufacturer and thus the one responsible for UDI compliance.  This is deeply influenced by FDA's statutory approach to "manufacture", which I won't delve into here unless requested to do so. 

Finally, the offline comment I received also seemed to assert that private labeling does NOT include the addition of the name of, and contact information for, a person who distributes the device. I presume that this offline assertion was triggered by the third paragraph of my preceding post where I generally implied that the opposite could be true. In other words, the offline comment I received seems to be saying that private labelers are not encompassed by FDA's UDI guidance statements like, "Distributors who only place their name and contact information on the label without changing the label any further are not considered [UDI] labelers". [emphasis added].

My interpretation differs from that offline assertion.  Specifically, regardless of whether a distributor simply adds a sticker with its company name and contact information to an OEM named/branded device, or if instead the private labeler has OEM authorization to market the OEM's device disguised as the private labeler's device (notwithstanding the required "Manufactured for" or "Distributed by" clarifier), either scenario may be encompassed by the UDI regulation labeler exclusion wording, "...except that the addition of the name of, and contact information for, a person who distributes the device...is not…a labeler" [emphasis added]. This is because either scenario is governed by the aforesaid Part 807 distributor exemptions [807.65(e) and 807.20(c)].  Accordingly, I don't believe that there is valid regulatory premise to declare that a private labeler must be the UDI labeler (unless it does so autonomously from the OEM).  For example, FDA investigators are instructed and mandated that if a "relabeler" distributes the device under its own name (thus becoming a private labeler) without otherwise changing the OEM's labeling, then the 807.65(e) and 807.20(c) exemptions apply.

------------------------------
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: 07-Jun-2023 16:15
From: Kevin Randall
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

Some other thoughts for consideration:

In the U.S., a "private labeler" is generally viewed and handled as a wholesale distributor who is simply marketing a version of a registered OEM manufacturer's device where such device has been labeled/branded by, and/or under license/authorization from, the registered OEM manufacturer.  In this common scenario, the private label distributor (wholesale distributor) is exempt from FDA registration and device listing (unless a foreign entity), and the private-label version of the OEM manufacturer's device is managed and listed and UDI labeled under the covering of the OEM manufacturer's FDA registration and quality system.

That remains the case even if the OEM manufacturer uses a contract manufacturer to fabricate/label the device.  In a contract manufacturing scenario, I still consider the OEM to be the one "causing" the label to be applied, not the wholesale distributor, though the implementation is being outsourced. In guidance, FDA gave an interpretive paraphrase of "Labeler" which I find insightful: "The labeler is responsible for compliance with the UDI requirements."

The wholesale distributor category has traditionally allowed, and the UDI regulation echoes, that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label doesn't exceed the aforesaid wholesale distributor exemption threshold, nor the UDI "labeler" threshold.  FDA has traditionally given the example of where a distributor simply places a "sticker" on the OEM's product to identify the distributor without obscuring or altering the OEM's regulated label/labeling.  FDA reiterates this in UDI guidance for the UDI context.

That said, FDA also reminds us that a private label distributor might sometimes trigger the UDI labeler threshold.  To help delineate such scenarios, we need to rely on FDA's overarching controls for manufacturers.  Specifically, if the wholesale distributor acts independent of the OEM and is doing the private labeling independent of the OEM, then that makes the wholesale distributor into a manufacturer who then has its own independent FDA registration, quality system, and UDI labeling obligations.  Indeed, when promulgating the UDI regulations, FDA said that, in most instances, the labeler would be the device manufacturer, yet that the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler (these are various types of manufacturing operations).  But again, if the distributor is simply adding its name and contact information without obscuring the OEM's regulated labeling, then such distributor hasn't become a manufacturer or UDI labeler.

Accordingly, as long as the private labeler stays under FDA's "wholesale distributor" categorization, then it need not bother with the obligations of a UDI Labeler, as that will already be covered by the OEM even for the private label versions of the OEM's devices being marketed by "private labelers" (i.e., authorized wholesale distributors).

------------------------------
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: 07-Jun-2023 00:46
From: Jay Crowley
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

In the development of the US UDI regulation, we "borrowed" the concept of "labeler" (as the responsible party) from CDER (NDCs) because "manufacturer" had too many meanings.  It was simply meant to recognize, and allow, the many different private labeling situations that occur in the US [by contrast, the EU MDR/IVDR certainly changes this conversation].  If the device is being commercialized as "your" device - then it is your device - and your UDI, etc,  In the US, it does not matter, for purposes of UDI, who physically manufacturers the device, who owns the 510k, etc.  Certainly, R&L needs to accurately reflect the roles and responsibilities of the various players.  But, private labeling occurs in all sectors of our space -  and the notion of responsible party for UDI should be straightforward.

------------------------------
Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States

Original Message:
Sent: 25-May-2023 06:07
From: Anonymous Member
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

This message was posted by a user wishing to remain anonymous

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.

Hi Jay. Many thanks for your messages and contributions.

• It is contrary to longstanding medical device regulation and the fundamental intent of the UDI regulations for anyone to universally mandate that a private label distributor be regulated as a manufacturer.  For example, during final promulgation of the UDI regulations, FDA accepted the conclusion that, "...where a third party private labeler is involved, it is still assumed that the specification developer is the UDI labeler..."  Over the years, I've repeatedly encountered FDA-ers (and x-FDAers) who misappropriate FDA's own requirements.  Mandating UDI labeler requirements onto private label distributors would be such an example.

• Private label distributors are generally just sales organizations who are unqualified and not resourced to manage medical device manufacturing and regulatory operations (yet FDA certainly allows anyone to attempt that endeavor if the entity so desires).  Trying to force those heavy burdens onto such a sales organization is contrary to public health, unnecessarily costly for such organization, and contrary to FDA medical device regulations (see my prior post and the preceding bullet of this current post).

• For the medical device industry, FDA uses and defines the terms "private label distributor" and "private label distribution" (see my prior post). Accordingly, it is inappropriate and nonsensical to suggest that medical device distributor requirements are somehow separate from private label distribution, or that the two are being confused.  Indeed, they are largely inseparable for regulatory intents and purposes (see my prior post and the next bullet of this current post).

• For its investigators and industry alike, FDA recognizes a device establishment operation that the agency calls, "Relabeler or repacker: distribute under own name...no change to device or existing labeling" [emphasis added] and then reminds us that such an entity is exempt from GMP, establishment registration, device listing, and, when an OEM holds the premarket authorization [e.g., 510(k)], also exempt from that too.

• FDA's ill-advised "borrowing" of the drug term "labeler" for the medical device UDI regulation is what has caused confusion in my humble opinion, and also that of the well-reputed author of the article I linked to in my prior post.  Attempts to force drug labeler paradigms/rules on medical device establishments are examples of such confusion and are in contravention of medical device regulation, including the UDI regulations.

Kevin - sorry, but I feel that this thread continues to confuse activities of a distributor with that of a company placing a device on the market under its own name/brand (aka, a private labeled device).  Private labeling exists in other sectors - especially the drug space - and it was from there that we "borrowed" the concept of labeler for purposes of the UDI regulation.  If a company is having a device "labeled" for them (e.g., having their trade name, brand name placed on the label) - then they are the labeler of the device and are responsible for the UDI of that device, including its GUDID submission (under their name).

I talked a lot about this during the development of the UDI regulation and after its final publication - and was hoping that we put this behind us.  I encourage anyone with questions to reach out to me directly - I am happy to discuss further.  Alternatively, I suggest looking at products from other industries (e.g., drugs, consumer products) - and you will see that the identification of the product belongs (is the responsibility of and points) to, to borrow a GS1 term, the "brand owner" of the device.

Thanks - Jay

Well...I'd originally tried not to get into too much depth about what is a "private labeler".  But offline I received a comment expressing concern that my prior post may be confusing or incorrect with respect to the definition of "private labeling".  So, let's dive deeper on that to be sure I've been clear.

The first paragraph of my preceding post was intended to convey that a private labeled device is (as the offline comment more directly stated), "...being sold as that private labeler's [own] device." [emphasis added].  My apologies if that wasn't clear from my prior post.  In other words, private labeling means that the device bears the private labeler's own name (meaning company name and/or brand name; I explain that further below) and contact information, rather than the OEM's.

As a related aside, I can think of two "official" places in FDA device regulations that address private labeling.  Specifically, those are 21 CFR 807.65(e) and also in the original Medical Device Reporting Part 803 preamble at 49 FR 36335 [where FDA echoes the intent of 807.65(e) and refers to a private label distributor as, "...a distributor that obtains a device from a manufacturer with the label already applied and that does not repackage or otherwise alter the device's package or label…"] [emphasis added].  I've also had FDA's DICE (at the time DSMICA) reiterate this explanation of private labelers and also confirm that it was "verified for accuracy by the appropriate CDRH Office or other FDA component".

Pursuant to 807.65(e), private label arrangements are generally considered by FDA to be wholesale or other distribution that is exempt from registration, listing, and quality system requirements (except for complaint handling), consequently meaning that such a private labeled device remains under the regulatory responsibility of the OEM.  For example, FDA's DICE (at the time DSMICA) reiterated this to me, along with clarification that the exempt distributor categorization remains for the private labelers when the OEM makes or authorizes the private labeled version for the private labeler (i.e., the private labeler doesn't do or arrange for the relabeling autonomously from the OEM).  Below, I've posted a link to an interesting article from a different author who also mentions this same kind of interpretation.

In other words, as I mentioned in my first post, the distributor exemptions may go away if the private labeling is being done by or for the private labeler autonomously from the OEM (i.e., without the OEM's knowledge/authorization, in which case the private labeler becomes the UDI labeler).

This background is important and governing because, while true that FDA "borrowed" the UDI "labeler" concept from the drug side, FDA apparently didn't realize the device regulatory contravention and confusion it would cause in the device space.  For a perspective on this, see this article.  Indeed, the broadness FDA envisioned and has tried to practice regarding the UDI "labeler" concept creates a regulatory contravention with the aforesaid Part 807 regulatory exemptions for private labelers.  Specifically, it is nonsensical and conflicts with governing FDA regulations [e.g., 807.65(e)] if FDA considers a private labeler to be the UDI labeler.  Why?  Because private labelers are exempt from GMP, establishment registration, and device listing and those are intrinsically needed for FDA enforcement of UDI compliance.

Accordingly, I would caution stakeholders against asserting that the UDI regulation and its definition of "labeler" somehow trump or undo the fundamental regulatory exemptions for private labelers in Part 807.  Instead, my understanding is that FDA wanted the UDI labeler concept to be flexible enough to allow firms wide logistical liberty for fulfilling the UDI requirements via various business models.  I don't believe it was FDA's intent for the UDI labeler obligations to be dictated by the chosen business model.  The aforesaid article gives additional supporting evidence for this interpretation.

Again, a bottom line is that, if a "private labeler" is doing so under the covering of the OEM's registration, device listings, quality system, 510(k), etc., then the OEM is the one who causes the label to be applied; consequently, the OEM is the UDI labeler in that scenario.  But if the "private labeler" is instead doing so autonomously from the OEM, then that's where the private labeler would generally exceed the Part 807 distributor exemptions and thus becomes a type of manufacturer and thus the one responsible for UDI compliance.  This is deeply influenced by FDA's statutory approach to "manufacture", which I won't delve into here unless requested to do so. 

Finally, the offline comment I received also seemed to assert that private labeling does NOT include the addition of the name of, and contact information for, a person who distributes the device. I presume that this offline assertion was triggered by the third paragraph of my preceding post where I generally implied that the opposite could be true. In other words, the offline comment I received seems to be saying that private labelers are not encompassed by FDA's UDI guidance statements like, "Distributors who only place their name and contact information on the label without changing the label any further are not considered [UDI] labelers". [emphasis added].

My interpretation differs from that offline assertion.  Specifically, regardless of whether a distributor simply adds a sticker with its company name and contact information to an OEM named/branded device, or if instead the private labeler has OEM authorization to market the OEM's device disguised as the private labeler's device (notwithstanding the required "Manufactured for" or "Distributed by" clarifier), either scenario may be encompassed by the UDI regulation labeler exclusion wording, "...except that the addition of the name of, and contact information for, a person who distributes the device...is not…a labeler" [emphasis added]. This is because either scenario is governed by the aforesaid Part 807 distributor exemptions [807.65(e) and 807.20(c)].  Accordingly, I don't believe that there is valid regulatory premise to declare that a private labeler must be the UDI labeler (unless it does so autonomously from the OEM).  For example, FDA investigators are instructed and mandated that if a "relabeler" distributes the device under its own name (thus becoming a private labeler) without otherwise changing the OEM's labeling, then the 807.65(e) and 807.20(c) exemptions apply.

------------------------------
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: 07-Jun-2023 16:15
From: Kevin Randall
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

Some other thoughts for consideration:

In the U.S., a "private labeler" is generally viewed and handled as a wholesale distributor who is simply marketing a version of a registered OEM manufacturer's device where such device has been labeled/branded by, and/or under license/authorization from, the registered OEM manufacturer.  In this common scenario, the private label distributor (wholesale distributor) is exempt from FDA registration and device listing (unless a foreign entity), and the private-label version of the OEM manufacturer's device is managed and listed and UDI labeled under the covering of the OEM manufacturer's FDA registration and quality system.

That remains the case even if the OEM manufacturer uses a contract manufacturer to fabricate/label the device.  In a contract manufacturing scenario, I still consider the OEM to be the one "causing" the label to be applied, not the wholesale distributor, though the implementation is being outsourced. In guidance, FDA gave an interpretive paraphrase of "Labeler" which I find insightful: "The labeler is responsible for compliance with the UDI requirements."

The wholesale distributor category has traditionally allowed, and the UDI regulation echoes, that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label doesn't exceed the aforesaid wholesale distributor exemption threshold, nor the UDI "labeler" threshold.  FDA has traditionally given the example of where a distributor simply places a "sticker" on the OEM's product to identify the distributor without obscuring or altering the OEM's regulated label/labeling.  FDA reiterates this in UDI guidance for the UDI context.

That said, FDA also reminds us that a private label distributor might sometimes trigger the UDI labeler threshold.  To help delineate such scenarios, we need to rely on FDA's overarching controls for manufacturers.  Specifically, if the wholesale distributor acts independent of the OEM and is doing the private labeling independent of the OEM, then that makes the wholesale distributor into a manufacturer who then has its own independent FDA registration, quality system, and UDI labeling obligations.  Indeed, when promulgating the UDI regulations, FDA said that, in most instances, the labeler would be the device manufacturer, yet that the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler (these are various types of manufacturing operations).  But again, if the distributor is simply adding its name and contact information without obscuring the OEM's regulated labeling, then such distributor hasn't become a manufacturer or UDI labeler.

Accordingly, as long as the private labeler stays under FDA's "wholesale distributor" categorization, then it need not bother with the obligations of a UDI Labeler, as that will already be covered by the OEM even for the private label versions of the OEM's devices being marketed by "private labelers" (i.e., authorized wholesale distributors).

------------------------------
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: 07-Jun-2023 00:46
From: Jay Crowley
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

In the development of the US UDI regulation, we "borrowed" the concept of "labeler" (as the responsible party) from CDER (NDCs) because "manufacturer" had too many meanings.  It was simply meant to recognize, and allow, the many different private labeling situations that occur in the US [by contrast, the EU MDR/IVDR certainly changes this conversation].  If the device is being commercialized as "your" device - then it is your device - and your UDI, etc,  In the US, it does not matter, for purposes of UDI, who physically manufacturers the device, who owns the 510k, etc.  Certainly, R&L needs to accurately reflect the roles and responsibilities of the various players.  But, private labeling occurs in all sectors of our space -  and the notion of responsible party for UDI should be straightforward.

------------------------------
Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States

Original Message:
Sent: 25-May-2023 06:07
From: Anonymous Member
Subject: Identifying the FDA "Device Labeler" for UDI on private label devices

This message was posted by a user wishing to remain anonymous

Hi All,

I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label," the SOP just indicates that both parties are responsible and accountable for figuring it out.

The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

Has anyone else had similar issues? I'd love to hear others' experiences.