Regulatory Open Forum

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

Thanks for the great questions Dan!

Your question "Am I misunderstanding something here?":

Specification development, relabeling, and repackaging are types of manufacturing.  So you are absolutely correct in that firms who are engaged in such activities must FDA-register and list.  This requirement is from section 510 of the FD&C Act [21 USC sec. 360(b), not to be confused with sec. 360b], and with implementing regulations at 21 CFR 807.20.

But the application of these fundamentals to private label scenarios can easily lead to misunderstandings.  Remember that the FDA registration obligation is for non-exempt “establishments” engaged in the “manufacture, preparation, propagation, compounding, assembly, or processing” of devices.  And such establishments must also list the devices once in U.S. commercial distribution.

In a nutshell, an “establishment” is a place where a device is manufactured, assembled, or otherwise processed [807.3(c)].  “Manufacture, preparation, propagation, compounding, assembly, or processing” means making devices by chemical, physical, biological, or other procedures [807.3(d)].  And as we both noted, manufacturing includes specification development and relabeling, thus requiring specification developers and relabelers to FDA-register and list.

But a private label firm’s exemption from these obligations is based on the premises that the private label firm is not actually making (physically or virtually) the private label version of the device; is not actually engaged in relabeling or other manufacturing operation; and is not the specification developer.  Consequently, the private label firm’s establishment is not the place where the device is manufactured, assembled, or otherwise processed.  Instead, the manufacturer / specification developer has simply granted permission for the private label firm to distribute an identical version of the specification developer’s device, except that the private label version bears the name and branding of the private label firm instead of the manufacturer’s name and brand.  (To Judy’s great point, this can create even more confusion if one misappropriates requirements such as Europe’s “own branding” and MDD requirements, which cause a firm to become the “manufacturer” by simple virtue of putting a device on the market under its own name.)

Confusion regarding U.S. private labeling can arise due in my opinion to the chicken-and-the-egg effect, where it might seem that the private label firm becomes the specification developer/manufacturer by having its name and branding on the device.  Yet as long as the original specification developer maintains ownership/control the specifications (i.e., the Device Master Record, including the labeling specifications for the private label variants), then the original specification developer remains the specification developer, and the private label firm’s ultimate role/function is effectively limited to that of a distributor.

But this exemption ends if the private label firm sponsors/makes (either by actual or virtual means) the labeling changes independently (i.e., outside the control/authorization of the specification developer).  In that case, the private label firm does indeed become the specification developer / manufacturer.

Your FDA registration/listing FAQ question "From this, I infer that the private label company and the manufacturer would both list the device.":

When I consider FDA’s website registration/listing FAQ #4 in light of the premises I described above, I infer that “we” and “our” refers to the specification developer / manufacturer as distinguished from “a number of companies” who are the private label firms.  In FDA’s answer, I infer that “your” and “you” are likewise referring to the specification developer/manufacturer, but not the private label firms.  In other words, when a manufacturer/specification developer authorizes its devices to be distributed by other firms under private label branding arrangements (i.e., contracts), then the private label branded versions, in addition to the specification developer’s “in-house” brand, must all be identified in the specification developer’s device listings under its corresponding 510(k).  In fact, one of the first things that must be entered in the FURLS database when doing a device listing is the governing 510(k).  But if the private label distributor adheres to the aforementioned statutory boundaries, then there is no statutory/regulatory basis for it to register and list.

For example, the FURLS system requires registrants to choose from the following categorizations when registering:

• Manufacture Medical Device
• Develop Specifications But Do Not Manufacture At This Facility
• Manufacture Medical Device for Another Party (Contract Manufacturer)
• Sterilize Medical Device for Another Party (Contract Sterilizer)
• Reprocess Single-Use Device
• Repack or Relabel Medical Device
• Remanufacture Medical Device
• Export Device to the United States But Perform No Other Operation on Device
• Manufacture Device in the United States for Export Only
• Complaint File Establishment per 21 CFR 820.198
• Foreign Private Label Distributor

So if a private label firm FDA-registers its establishment, then it would inevitably categorize itself as some type of manufacturer. Remember that the FDA considers manufacturers/specification developers to have ownership/control over the specifications, and/or device quality. Therefore if a private label firm identifies itself as a manufacturer via FURLS, then the FDA will (commensurate with device class) enroll the private label firm in the establishment inspection queue, consequently subjecting the private label firm to establishment inspections in order to enforce compliance with applicable good manufacturing practices, among other requirements. One of my private label distributor clients made this mistake [before they were my client of course :) ]. Because it registered itself as the manufacturer, FDA arrived in due course and performed a full GMP inspection of the firm’s facility. But the facility was just a business office and warehouse with no actual device development/manufacturing activities, and no ultimate ownership/control over such activities for the devices being distributed. This ultimately led to a lengthy GMP Warning Letter that proved to be rather tricky to get cleared.  In the end, the FDA ultimately accepted the re-categorization of the firm and its exclusion from FDA establishment registration and listing for the subject devices.

Your question "The question came up, for me, in the context of UDI...":

You are one of the foremost experts regarding UDI (and for many other topics too). So in my mind, your interpretation of the UDI requirements carries a lot of weight. Yet practicing UDI in the real world of OEM’s, contract manufactures, and private label firms can be a very convoluted maze. Heck, even FDA has had a hard time (in my opinion) getting a uniform grasp on all of the various practical permutations affecting UDI. Nonetheless, after carefully studying the UDI regulations and especially the Preamble, I've derived some basic guidelines that I use to decide who is the UDI “labeler” (which may not always be the person identified on the label).

I’d be happy to share my corresponding thoughts with you and/or the Forum. But that will take some explaining, and seems to be outside the scope of this particular discussion thread. So I could add a response to the Forum thread to which I believe you’re referring. Or I could do that with you offline. Let me know which is preferred.

All the best,

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

Thank you very much for the well reasoned and detailed answer. It will take me some time to digest it.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 12-Jul-2016 14:28
From: Kevin Randall
Subject: Private Label Agreements

Thanks for the great questions Dan!

Your question "Am I misunderstanding something here?":

Specification development, relabeling, and repackaging are types of manufacturing.  So you are absolutely correct in that firms who are engaged in such activities must FDA-register and list.  This requirement is from section 510 of the FD&C Act [21 USC sec. 360(b), not to be confused with sec. 360b], and with implementing regulations at 21 CFR 807.20.

But the application of these fundamentals to private label scenarios can easily lead to misunderstandings.  Remember that the FDA registration obligation is for non-exempt “establishments” engaged in the “manufacture, preparation, propagation, compounding, assembly, or processing” of devices.  And such establishments must also list the devices once in U.S. commercial distribution.

In a nutshell, an “establishment” is a place where a device is manufactured, assembled, or otherwise processed [807.3(c)].  “Manufacture, preparation, propagation, compounding, assembly, or processing” means making devices by chemical, physical, biological, or other procedures [807.3(d)].  And as we both noted, manufacturing includes specification development and relabeling, thus requiring specification developers and relabelers to FDA-register and list.

But a private label firm’s exemption from these obligations is based on the premises that the private label firm is not actually making (physically or virtually) the private label version of the device; is not actually engaged in relabeling or other manufacturing operation; and is not the specification developer.  Consequently, the private label firm’s establishment is not the place where the device is manufactured, assembled, or otherwise processed.  Instead, the manufacturer / specification developer has simply granted permission for the private label firm to distribute an identical version of the specification developer’s device, except that the private label version bears the name and branding of the private label firm instead of the manufacturer’s name and brand.  (To Judy’s great point, this can create even more confusion if one misappropriates requirements such as Europe’s “own branding” and MDD requirements, which cause a firm to become the “manufacturer” by simple virtue of putting a device on the market under its own name.)

Confusion regarding U.S. private labeling can arise due in my opinion to the chicken-and-the-egg effect, where it might seem that the private label firm becomes the specification developer/manufacturer by having its name and branding on the device.  Yet as long as the original specification developer maintains ownership/control the specifications (i.e., the Device Master Record, including the labeling specifications for the private label variants), then the original specification developer remains the specification developer, and the private label firm’s ultimate role/function is effectively limited to that of a distributor.

But this exemption ends if the private label firm sponsors/makes (either by actual or virtual means) the labeling changes independently (i.e., outside the control/authorization of the specification developer).  In that case, the private label firm does indeed become the specification developer / manufacturer.

Your FDA registration/listing FAQ question "From this, I infer that the private label company and the manufacturer would both list the device.":

When I consider FDA’s website registration/listing FAQ #4 in light of the premises I described above, I infer that “we” and “our” refers to the specification developer / manufacturer as distinguished from “a number of companies” who are the private label firms.  In FDA’s answer, I infer that “your” and “you” are likewise referring to the specification developer/manufacturer, but not the private label firms.  In other words, when a manufacturer/specification developer authorizes its devices to be distributed by other firms under private label branding arrangements (i.e., contracts), then the private label branded versions, in addition to the specification developer’s “in-house” brand, must all be identified in the specification developer’s device listings under its corresponding 510(k).  In fact, one of the first things that must be entered in the FURLS database when doing a device listing is the governing 510(k).  But if the private label distributor adheres to the aforementioned statutory boundaries, then there is no statutory/regulatory basis for it to register and list.

For example, the FURLS system requires registrants to choose from the following categorizations when registering:

• Manufacture Medical Device
• Develop Specifications But Do Not Manufacture At This Facility
• Manufacture Medical Device for Another Party (Contract Manufacturer)
• Sterilize Medical Device for Another Party (Contract Sterilizer)
• Reprocess Single-Use Device
• Repack or Relabel Medical Device
• Remanufacture Medical Device
• Export Device to the United States But Perform No Other Operation on Device
• Manufacture Device in the United States for Export Only
• Complaint File Establishment per 21 CFR 820.198
• Foreign Private Label Distributor

So if a private label firm FDA-registers its establishment, then it would inevitably categorize itself as some type of manufacturer. Remember that the FDA considers manufacturers/specification developers to have ownership/control over the specifications, and/or device quality. Therefore if a private label firm identifies itself as a manufacturer via FURLS, then the FDA will (commensurate with device class) enroll the private label firm in the establishment inspection queue, consequently subjecting the private label firm to establishment inspections in order to enforce compliance with applicable good manufacturing practices, among other requirements. One of my private label distributor clients made this mistake [before they were my client of course :) ]. Because it registered itself as the manufacturer, FDA arrived in due course and performed a full GMP inspection of the firm’s facility. But the facility was just a business office and warehouse with no actual device development/manufacturing activities, and no ultimate ownership/control over such activities for the devices being distributed. This ultimately led to a lengthy GMP Warning Letter that proved to be rather tricky to get cleared.  In the end, the FDA ultimately accepted the re-categorization of the firm and its exclusion from FDA establishment registration and listing for the subject devices.

Your question "The question came up, for me, in the context of UDI...":

You are one of the foremost experts regarding UDI (and for many other topics too). So in my mind, your interpretation of the UDI requirements carries a lot of weight. Yet practicing UDI in the real world of OEM’s, contract manufactures, and private label firms can be a very convoluted maze. Heck, even FDA has had a hard time (in my opinion) getting a uniform grasp on all of the various practical permutations affecting UDI. Nonetheless, after carefully studying the UDI regulations and especially the Preamble, I've derived some basic guidelines that I use to decide who is the UDI “labeler” (which may not always be the person identified on the label).

I’d be happy to share my corresponding thoughts with you and/or the Forum. But that will take some explaining, and seems to be outside the scope of this particular discussion thread. So I could add a response to the Forum thread to which I believe you’re referring. Or I could do that with you offline. Let me know which is preferred.

All the best,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2016 by ComplianceAcuity. All rights reserved to credited usage within the RAPS Regulatory Forum.

Original Message:
Sent: 12-Jul-2016 06:54
From: Dan O'Leary
Subject: Private Label Agreements

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 11-Jul-2016 20:10
From: Kevin Randall
Subject: Private Label Agreements

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 11-Jul-2016 18:25
From: Lauren Parker
Subject: Private Label Agreements

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

------------------------------
Lauren Parker
CA
United States
------------------------------

Thanks for the great questions Dan!

Your question "Am I misunderstanding something here?":

Specification development, relabeling, and repackaging are types of manufacturing.  So you are absolutely correct in that firms who are engaged in such activities must FDA-register and list.  This requirement is from section 510 of the FD&C Act [21 USC sec. 360(b), not to be confused with sec. 360b], and with implementing regulations at 21 CFR 807.20.

But the application of these fundamentals to private label scenarios can easily lead to misunderstandings.  Remember that the FDA registration obligation is for non-exempt “establishments” engaged in the “manufacture, preparation, propagation, compounding, assembly, or processing” of devices.  And such establishments must also list the devices once in U.S. commercial distribution.

In a nutshell, an “establishment” is a place where a device is manufactured, assembled, or otherwise processed [807.3(c)].  “Manufacture, preparation, propagation, compounding, assembly, or processing” means making devices by chemical, physical, biological, or other procedures [807.3(d)].  And as we both noted, manufacturing includes specification development and relabeling, thus requiring specification developers and relabelers to FDA-register and list.

But a private label firm’s exemption from these obligations is based on the premises that the private label firm is not actually making (physically or virtually) the private label version of the device; is not actually engaged in relabeling or other manufacturing operation; and is not the specification developer.  Consequently, the private label firm’s establishment is not the place where the device is manufactured, assembled, or otherwise processed.  Instead, the manufacturer / specification developer has simply granted permission for the private label firm to distribute an identical version of the specification developer’s device, except that the private label version bears the name and branding of the private label firm instead of the manufacturer’s name and brand.  (To Judy’s great point, this can create even more confusion if one misappropriates requirements such as Europe’s “own branding” and MDD requirements, which cause a firm to become the “manufacturer” by simple virtue of putting a device on the market under its own name.)

Confusion regarding U.S. private labeling can arise due in my opinion to the chicken-and-the-egg effect, where it might seem that the private label firm becomes the specification developer/manufacturer by having its name and branding on the device.  Yet as long as the original specification developer maintains ownership/control the specifications (i.e., the Device Master Record, including the labeling specifications for the private label variants), then the original specification developer remains the specification developer, and the private label firm’s ultimate role/function is effectively limited to that of a distributor.

But this exemption ends if the private label firm sponsors/makes (either by actual or virtual means) the labeling changes independently (i.e., outside the control/authorization of the specification developer).  In that case, the private label firm does indeed become the specification developer / manufacturer.

Your FDA registration/listing FAQ question "From this, I infer that the private label company and the manufacturer would both list the device.":

When I consider FDA’s website registration/listing FAQ #4 in light of the premises I described above, I infer that “we” and “our” refers to the specification developer / manufacturer as distinguished from “a number of companies” who are the private label firms.  In FDA’s answer, I infer that “your” and “you” are likewise referring to the specification developer/manufacturer, but not the private label firms.  In other words, when a manufacturer/specification developer authorizes its devices to be distributed by other firms under private label branding arrangements (i.e., contracts), then the private label branded versions, in addition to the specification developer’s “in-house” brand, must all be identified in the specification developer’s device listings under its corresponding 510(k).  In fact, one of the first things that must be entered in the FURLS database when doing a device listing is the governing 510(k).  But if the private label distributor adheres to the aforementioned statutory boundaries, then there is no statutory/regulatory basis for it to register and list.

For example, the FURLS system requires registrants to choose from the following categorizations when registering:

• Manufacture Medical Device
• Develop Specifications But Do Not Manufacture At This Facility
• Manufacture Medical Device for Another Party (Contract Manufacturer)
• Sterilize Medical Device for Another Party (Contract Sterilizer)
• Reprocess Single-Use Device
• Repack or Relabel Medical Device
• Remanufacture Medical Device
• Export Device to the United States But Perform No Other Operation on Device
• Manufacture Device in the United States for Export Only
• Complaint File Establishment per 21 CFR 820.198
• Foreign Private Label Distributor

So if a private label firm FDA-registers its establishment, then it would inevitably categorize itself as some type of manufacturer. Remember that the FDA considers manufacturers/specification developers to have ownership/control over the specifications, and/or device quality. Therefore if a private label firm identifies itself as a manufacturer via FURLS, then the FDA will (commensurate with device class) enroll the private label firm in the establishment inspection queue, consequently subjecting the private label firm to establishment inspections in order to enforce compliance with applicable good manufacturing practices, among other requirements. One of my private label distributor clients made this mistake [before they were my client of course :) ]. Because it registered itself as the manufacturer, FDA arrived in due course and performed a full GMP inspection of the firm’s facility. But the facility was just a business office and warehouse with no actual device development/manufacturing activities, and no ultimate ownership/control over such activities for the devices being distributed. This ultimately led to a lengthy GMP Warning Letter that proved to be rather tricky to get cleared.  In the end, the FDA ultimately accepted the re-categorization of the firm and its exclusion from FDA establishment registration and listing for the subject devices.

Your question "The question came up, for me, in the context of UDI...":

You are one of the foremost experts regarding UDI (and for many other topics too). So in my mind, your interpretation of the UDI requirements carries a lot of weight. Yet practicing UDI in the real world of OEM’s, contract manufactures, and private label firms can be a very convoluted maze. Heck, even FDA has had a hard time (in my opinion) getting a uniform grasp on all of the various practical permutations affecting UDI. Nonetheless, after carefully studying the UDI regulations and especially the Preamble, I've derived some basic guidelines that I use to decide who is the UDI “labeler” (which may not always be the person identified on the label).

I’d be happy to share my corresponding thoughts with you and/or the Forum. But that will take some explaining, and seems to be outside the scope of this particular discussion thread. So I could add a response to the Forum thread to which I believe you’re referring. Or I could do that with you offline. Let me know which is preferred.

All the best,

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

Dear Kevin,

Thank you for the detailed discussion! I for one would be interested in your explanations about UDI labelers, as we are being asked many questions by private label customers in the USA who are confused about who should be entering what when they Import devices from us, a foreign manufacturer. Please let me know where I can find your UDI "thread".

Thanks,

Deborah 

Thanks for the great questions Dan!

Your question "Am I misunderstanding something here?":

Specification development, relabeling, and repackaging are types of manufacturing.  So you are absolutely correct in that firms who are engaged in such activities must FDA-register and list.  This requirement is from section 510 of the FD&C Act [21 USC sec. 360(b), not to be confused with sec. 360b], and with implementing regulations at 21 CFR 807.20.

But the application of these fundamentals to private label scenarios can easily lead to misunderstandings.  Remember that the FDA registration obligation is for non-exempt “establishments” engaged in the “manufacture, preparation, propagation, compounding, assembly, or processing” of devices.  And such establishments must also list the devices once in U.S. commercial distribution.

In a nutshell, an “establishment” is a place where a device is manufactured, assembled, or otherwise processed [807.3(c)].  “Manufacture, preparation, propagation, compounding, assembly, or processing” means making devices by chemical, physical, biological, or other procedures [807.3(d)].  And as we both noted, manufacturing includes specification development and relabeling, thus requiring specification developers and relabelers to FDA-register and list.

But a private label firm’s exemption from these obligations is based on the premises that the private label firm is not actually making (physically or virtually) the private label version of the device; is not actually engaged in relabeling or other manufacturing operation; and is not the specification developer.  Consequently, the private label firm’s establishment is not the place where the device is manufactured, assembled, or otherwise processed.  Instead, the manufacturer / specification developer has simply granted permission for the private label firm to distribute an identical version of the specification developer’s device, except that the private label version bears the name and branding of the private label firm instead of the manufacturer’s name and brand.  (To Judy’s great point, this can create even more confusion if one misappropriates requirements such as Europe’s “own branding” and MDD requirements, which cause a firm to become the “manufacturer” by simple virtue of putting a device on the market under its own name.)

Confusion regarding U.S. private labeling can arise due in my opinion to the chicken-and-the-egg effect, where it might seem that the private label firm becomes the specification developer/manufacturer by having its name and branding on the device.  Yet as long as the original specification developer maintains ownership/control the specifications (i.e., the Device Master Record, including the labeling specifications for the private label variants), then the original specification developer remains the specification developer, and the private label firm’s ultimate role/function is effectively limited to that of a distributor.

But this exemption ends if the private label firm sponsors/makes (either by actual or virtual means) the labeling changes independently (i.e., outside the control/authorization of the specification developer).  In that case, the private label firm does indeed become the specification developer / manufacturer.

Your FDA registration/listing FAQ question "From this, I infer that the private label company and the manufacturer would both list the device.":

When I consider FDA’s website registration/listing FAQ #4 in light of the premises I described above, I infer that “we” and “our” refers to the specification developer / manufacturer as distinguished from “a number of companies” who are the private label firms.  In FDA’s answer, I infer that “your” and “you” are likewise referring to the specification developer/manufacturer, but not the private label firms.  In other words, when a manufacturer/specification developer authorizes its devices to be distributed by other firms under private label branding arrangements (i.e., contracts), then the private label branded versions, in addition to the specification developer’s “in-house” brand, must all be identified in the specification developer’s device listings under its corresponding 510(k).  In fact, one of the first things that must be entered in the FURLS database when doing a device listing is the governing 510(k).  But if the private label distributor adheres to the aforementioned statutory boundaries, then there is no statutory/regulatory basis for it to register and list.

For example, the FURLS system requires registrants to choose from the following categorizations when registering:

• Manufacture Medical Device
• Develop Specifications But Do Not Manufacture At This Facility
• Manufacture Medical Device for Another Party (Contract Manufacturer)
• Sterilize Medical Device for Another Party (Contract Sterilizer)
• Reprocess Single-Use Device
• Repack or Relabel Medical Device
• Remanufacture Medical Device
• Export Device to the United States But Perform No Other Operation on Device
• Manufacture Device in the United States for Export Only
• Complaint File Establishment per 21 CFR 820.198
• Foreign Private Label Distributor

So if a private label firm FDA-registers its establishment, then it would inevitably categorize itself as some type of manufacturer. Remember that the FDA considers manufacturers/specification developers to have ownership/control over the specifications, and/or device quality. Therefore if a private label firm identifies itself as a manufacturer via FURLS, then the FDA will (commensurate with device class) enroll the private label firm in the establishment inspection queue, consequently subjecting the private label firm to establishment inspections in order to enforce compliance with applicable good manufacturing practices, among other requirements. One of my private label distributor clients made this mistake [before they were my client of course :) ]. Because it registered itself as the manufacturer, FDA arrived in due course and performed a full GMP inspection of the firm’s facility. But the facility was just a business office and warehouse with no actual device development/manufacturing activities, and no ultimate ownership/control over such activities for the devices being distributed. This ultimately led to a lengthy GMP Warning Letter that proved to be rather tricky to get cleared.  In the end, the FDA ultimately accepted the re-categorization of the firm and its exclusion from FDA establishment registration and listing for the subject devices.

Your question "The question came up, for me, in the context of UDI...":

You are one of the foremost experts regarding UDI (and for many other topics too). So in my mind, your interpretation of the UDI requirements carries a lot of weight. Yet practicing UDI in the real world of OEM’s, contract manufactures, and private label firms can be a very convoluted maze. Heck, even FDA has had a hard time (in my opinion) getting a uniform grasp on all of the various practical permutations affecting UDI. Nonetheless, after carefully studying the UDI regulations and especially the Preamble, I've derived some basic guidelines that I use to decide who is the UDI “labeler” (which may not always be the person identified on the label).

I’d be happy to share my corresponding thoughts with you and/or the Forum. But that will take some explaining, and seems to be outside the scope of this particular discussion thread. So I could add a response to the Forum thread to which I believe you’re referring. Or I could do that with you offline. Let me know which is preferred.

All the best,

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

Dear Kevin,

Thank you for the detailed discussion! I for one would be interested in your explanations about UDI labelers, as we are being asked many questions by private label customers in the USA who are confused about who should be entering what when they Import devices from us, a foreign manufacturer. Please let me know where I can find your UDI "thread".

Thanks,

Deborah 

------------------------------
Deborah Ockert
Regulatory Affairs
DMG Dental-Material Gesellschaft mbh
Hamburg
Germany

Original Message:
Sent: 12-Jul-2016 14:28
From: Kevin Randall
Subject: Private Label Agreements

Thanks for the great questions Dan!

Your question "Am I misunderstanding something here?":

Specification development, relabeling, and repackaging are types of manufacturing.  So you are absolutely correct in that firms who are engaged in such activities must FDA-register and list.  This requirement is from section 510 of the FD&C Act [21 USC sec. 360(b), not to be confused with sec. 360b], and with implementing regulations at 21 CFR 807.20.

But the application of these fundamentals to private label scenarios can easily lead to misunderstandings.  Remember that the FDA registration obligation is for non-exempt “establishments” engaged in the “manufacture, preparation, propagation, compounding, assembly, or processing” of devices.  And such establishments must also list the devices once in U.S. commercial distribution.

In a nutshell, an “establishment” is a place where a device is manufactured, assembled, or otherwise processed [807.3(c)].  “Manufacture, preparation, propagation, compounding, assembly, or processing” means making devices by chemical, physical, biological, or other procedures [807.3(d)].  And as we both noted, manufacturing includes specification development and relabeling, thus requiring specification developers and relabelers to FDA-register and list.

But a private label firm’s exemption from these obligations is based on the premises that the private label firm is not actually making (physically or virtually) the private label version of the device; is not actually engaged in relabeling or other manufacturing operation; and is not the specification developer.  Consequently, the private label firm’s establishment is not the place where the device is manufactured, assembled, or otherwise processed.  Instead, the manufacturer / specification developer has simply granted permission for the private label firm to distribute an identical version of the specification developer’s device, except that the private label version bears the name and branding of the private label firm instead of the manufacturer’s name and brand.  (To Judy’s great point, this can create even more confusion if one misappropriates requirements such as Europe’s “own branding” and MDD requirements, which cause a firm to become the “manufacturer” by simple virtue of putting a device on the market under its own name.)

Confusion regarding U.S. private labeling can arise due in my opinion to the chicken-and-the-egg effect, where it might seem that the private label firm becomes the specification developer/manufacturer by having its name and branding on the device.  Yet as long as the original specification developer maintains ownership/control the specifications (i.e., the Device Master Record, including the labeling specifications for the private label variants), then the original specification developer remains the specification developer, and the private label firm’s ultimate role/function is effectively limited to that of a distributor.

But this exemption ends if the private label firm sponsors/makes (either by actual or virtual means) the labeling changes independently (i.e., outside the control/authorization of the specification developer).  In that case, the private label firm does indeed become the specification developer / manufacturer.

Your FDA registration/listing FAQ question "From this, I infer that the private label company and the manufacturer would both list the device.":

When I consider FDA’s website registration/listing FAQ #4 in light of the premises I described above, I infer that “we” and “our” refers to the specification developer / manufacturer as distinguished from “a number of companies” who are the private label firms.  In FDA’s answer, I infer that “your” and “you” are likewise referring to the specification developer/manufacturer, but not the private label firms.  In other words, when a manufacturer/specification developer authorizes its devices to be distributed by other firms under private label branding arrangements (i.e., contracts), then the private label branded versions, in addition to the specification developer’s “in-house” brand, must all be identified in the specification developer’s device listings under its corresponding 510(k).  In fact, one of the first things that must be entered in the FURLS database when doing a device listing is the governing 510(k).  But if the private label distributor adheres to the aforementioned statutory boundaries, then there is no statutory/regulatory basis for it to register and list.

For example, the FURLS system requires registrants to choose from the following categorizations when registering:

• Manufacture Medical Device
• Develop Specifications But Do Not Manufacture At This Facility
• Manufacture Medical Device for Another Party (Contract Manufacturer)
• Sterilize Medical Device for Another Party (Contract Sterilizer)
• Reprocess Single-Use Device
• Repack or Relabel Medical Device
• Remanufacture Medical Device
• Export Device to the United States But Perform No Other Operation on Device
• Manufacture Device in the United States for Export Only
• Complaint File Establishment per 21 CFR 820.198
• Foreign Private Label Distributor

So if a private label firm FDA-registers its establishment, then it would inevitably categorize itself as some type of manufacturer. Remember that the FDA considers manufacturers/specification developers to have ownership/control over the specifications, and/or device quality. Therefore if a private label firm identifies itself as a manufacturer via FURLS, then the FDA will (commensurate with device class) enroll the private label firm in the establishment inspection queue, consequently subjecting the private label firm to establishment inspections in order to enforce compliance with applicable good manufacturing practices, among other requirements. One of my private label distributor clients made this mistake [before they were my client of course :) ]. Because it registered itself as the manufacturer, FDA arrived in due course and performed a full GMP inspection of the firm’s facility. But the facility was just a business office and warehouse with no actual device development/manufacturing activities, and no ultimate ownership/control over such activities for the devices being distributed. This ultimately led to a lengthy GMP Warning Letter that proved to be rather tricky to get cleared.  In the end, the FDA ultimately accepted the re-categorization of the firm and its exclusion from FDA establishment registration and listing for the subject devices.

Your question "The question came up, for me, in the context of UDI...":

You are one of the foremost experts regarding UDI (and for many other topics too). So in my mind, your interpretation of the UDI requirements carries a lot of weight. Yet practicing UDI in the real world of OEM’s, contract manufactures, and private label firms can be a very convoluted maze. Heck, even FDA has had a hard time (in my opinion) getting a uniform grasp on all of the various practical permutations affecting UDI. Nonetheless, after carefully studying the UDI regulations and especially the Preamble, I've derived some basic guidelines that I use to decide who is the UDI “labeler” (which may not always be the person identified on the label).

I’d be happy to share my corresponding thoughts with you and/or the Forum. But that will take some explaining, and seems to be outside the scope of this particular discussion thread. So I could add a response to the Forum thread to which I believe you’re referring. Or I could do that with you offline. Let me know which is preferred.

All the best,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2016 by ComplianceAcuity. All rights reserved to credited usage within the RAPS Regulatory Forum.

Original Message:
Sent: 12-Jul-2016 06:54
From: Dan O'Leary
Subject: Private Label Agreements

Kevin,

I find your answer interesting, but it leaves me confused about another issue.

You say, “FDA typically regulates private label entities as wholesale distributors.” A “Domestic Distributor that does not import device” according to the FDA website, does not have to register and list.

However, I have always believe that if a company put a device on the market under its own name, but doesn’t manufacture the device, then it must register in some role. The most likely roles are specification developer or relabeler.

Am I misunderstanding something here?

The second issue comes up with the manufacturer’s listing. The FDA website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm) has an FAQ about registration with the following.

“4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each private-label device?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.”

From this, I infer that the private label company and the manufacturer would both list the device.

The question came up, for me, in the context of UDI. I offered the opinion that the private label company is the labeler under the UDI rule because they “cause a label to be applied to a device”, and not the manufacturer. Consequently, the Device Identifier codes the identity of the private labeler (not the manufacturer) and the private label company is responsible to populate GUDID.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 11-Jul-2016 20:10
From: Kevin Randall
Subject: Private Label Agreements

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 11-Jul-2016 18:25
From: Lauren Parker
Subject: Private Label Agreements

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

------------------------------
Lauren Parker
CA
United States
------------------------------

FDA typically regulates private label entities as wholesale distributors.  Domestic distributors are not responsible for the statutory/regulatory requirements applicable to the "manufacturer".  In other words, there is no U.S. statutory/regulatory basis for a private label entity to assume ultimate liability for the manufacturer's statutory/regulatory obligations (such as recalls and supplier controls).

In order for FDA to hold the private label entity responsible for the manufacturer's obligations, the private label entity must itself become the statutory manufacturer by taking control/ownership of the specifications and the 510(k), and by FDA-registering itself as the statutory manufacturer, among other things.

Moreover, there can only be one owner of a particular 510(k). Consequently, each private label entity who wants to own/control the specifications must hold its own 510(k).

These statutory/regulatory requirements remain in force regardless of what contractual arrangements are in place between the firms involved. In other words, the FDA will still knock on the statutory manufacturer’s door when enforcing effectiveness of the recalls, supplier controls, etc., even if the manufacturer contracts / outsources handling of recalls, supplier controls, etc., to a third party.

Hope this helps.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.

I'd like to hear from anyone that has extensive experience writing private label contracts. My company execs. want to add some of our private label customers to our current 510K's (same formulas as our own product's 510k, but would be labelled w/ our customer's labels). They are convinced that we can eliminate our liability as a manufacturer of private label products by entering into contractual agreements w/ our private label customers in which they agree to assume liability for product recalls, supplier controls, etc. even though these customers would be under our 510K number. I have not ever heard of such a thing & have assumed that we would ultimately be responsible for these things regardless of any agreements to the contrary due to the fact that we own the 510K. Any insight would be much appreciated. Thanks.