Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

Good day Anon,

When you are speaking about the FURLS site, assuming you are talking about US FDA, then any company which takes regulatory responsibility would need to list their device in the Medical Device Listing.  So as an example, if the original company sells it under PMA P201234 and lists as Product X.  If company B sells as Product Y private labelled this would be linked to P201234 and would list medical device as Product Y.  Just keep in mind when a company private labels a finished medical device they are taking on the regulatory responsibility (this can be given to or shared with the original manufacturer) but Company B does need to register and list the medical device.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Aug-2022 13:40
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

This message was posted by a user wishing to remain anonymous

Dear Anon

I think Richard is confusing the FDA requirements with other regions. Be advised that the FDA views private labelers different than most other regions. Outside of the US (Canada for example), private labelers are considered the legal manufacturer and bear the responsibility for licensing, summary reporting (postmarket surveillance), recalls and such related to the product they have applied their name/brand to. In the US a private labeler is not viewed as the legal manufacturer and does not have listing requirements specific to the private labeled product. It is the responsibility of the owner of the 510k/PMA to add the private labelers brand to their listing of proprietary names for that 510k/PMA. The private labeler only has registration and listing requirements if they are involved in other activities outside of the private labeled device. One point of confusion is although there is no listing requirement on FURLS, the FDA does view the private labeler as the one causing the label to be applied to the device as such must assign a UDI and register the UDI in the GUDID database. I hope that helps clarify.
Original Message:
Sent: 17-Aug-2022 05:36
From: Richard Vincins
Subject: Private labels registration

Good day Anon,

When you are speaking about the FURLS site, assuming you are talking about US FDA, then any company which takes regulatory responsibility would need to list their device in the Medical Device Listing.  So as an example, if the original company sells it under PMA P201234 and lists as Product X.  If company B sells as Product Y private labelled this would be linked to P201234 and would list medical device as Product Y.  Just keep in mind when a company private labels a finished medical device they are taking on the regulatory responsibility (this can be given to or shared with the original manufacturer) but Company B does need to register and list the medical device.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 16-Aug-2022 13:40
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

Yes, in general, each private label should be registered.

Sent from my iPhone


Original Message:
Sent: 8/16/2022 1:40:00 PM
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

Hello Anon,

No, I am not confusing the US FDA requirements with other regulatory regions.  Just as in the United States as other regions, whosever name is listed as the "Manufacturer" on the device labelling is considered the legal manufacturer, Manufacturer, regulatory responsible - whichever terminology you want to use.  However, unlike in other regions, US FDA does allow the designation of Manufactured By and Manufactured For.  This does give more flexibility for private labellers distributing product in the United States.  Also note there is no such terminology as "private labeller" in the United States regulations.

I disagree with the Medical Device Listing you are stating, because it clearly depends on the relationship of the original manufacturer and the private labelling company.  And what name is listed on the final device labelling.  If Company A the original manufacturer is NOT going to take the regulatory responsibility, then indeed Company B must list the medical device under their name  (and there should be agreements in place).  Please explain how in your example the owner of the 510(k), the original manufacturer, would list another product which is being sold, labelled, and managed by Company B.  In your example, this would be a Manufacturer/Contract Manufacturer relationship and so the original company as the "contract manufacturer" would list the products they are making for Company B.  This same process holds true for "virtual manufacturers" whose name is on the labelling, but the product is being made by another company, a contract manufacturer, ... they would also need to list the medical device they are making for another company.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 17-Aug-2022 10:59
From: Joy Frestedt
Subject: Private labels registration

Yes, in general, each private label should be registered.

Sent from my iPhone


Original Message:
Sent: 8/16/2022 1:40:00 PM
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

This message was posted by a user wishing to remain anonymous

Agreed it completely depends on the relationship of the original manufacturer and the private labeling company. Normally "private labeling", although not defined in the regulation, generally refers a company only applying their brand to the device but not assuming any specification developer or manufacturing activities.

Domestic distributors (company B) are not required to register with the FDA. A product may be private labeled for a domestic distributor with "Manufactured For" Or "Distributed By" associated with their name. The FDA does not currently require that the manufacturer name (Company A) also appear on the device labeling. In this instance the only listing in FURLS describing this relationship will be the inclusion of the proprietary name of the distributor (Company B) under the manfacturer's (Company A) listing. Company B, solely acting as a domestic distributor, has no listing requirements of their own specifically in relation to the private labeled device in this instance. If the original question was in relation to this type of arrangement, then the answer is there is no listing requirements.
Original Message:
Sent: 23-Aug-2022 04:45
From: Richard Vincins
Subject: Private labels registration

Hello Anon,

No, I am not confusing the US FDA requirements with other regulatory regions.  Just as in the United States as other regions, whosever name is listed as the "Manufacturer" on the device labelling is considered the legal manufacturer, Manufacturer, regulatory responsible - whichever terminology you want to use.  However, unlike in other regions, US FDA does allow the designation of Manufactured By and Manufactured For.  This does give more flexibility for private labellers distributing product in the United States.  Also note there is no such terminology as "private labeller" in the United States regulations.

I disagree with the Medical Device Listing you are stating, because it clearly depends on the relationship of the original manufacturer and the private labelling company.  And what name is listed on the final device labelling.  If Company A the original manufacturer is NOT going to take the regulatory responsibility, then indeed Company B must list the medical device under their name  (and there should be agreements in place).  Please explain how in your example the owner of the 510(k), the original manufacturer, would list another product which is being sold, labelled, and managed by Company B.  In your example, this would be a Manufacturer/Contract Manufacturer relationship and so the original company as the "contract manufacturer" would list the products they are making for Company B.  This same process holds true for "virtual manufacturers" whose name is on the labelling, but the product is being made by another company, a contract manufacturer, ... they would also need to list the medical device they are making for another company.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 17-Aug-2022 10:59
From: Joy Frestedt
Subject: Private labels registration

Yes, in general, each private label should be registered.

Sent from my iPhone


Original Message:
Sent: 8/16/2022 1:40:00 PM
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

This message was posted by a user wishing to remain anonymous

Hi, 

I have a follow-up question to my inquiry above. If the same company manufactures and sells both the original brand name and the private label name (for that brand), does that company have to list and register both names? Or can they just register the original brand name since they have the same 510K and they are both under the same manufacture?
Original Message:
Sent: 24-Aug-2022 09:33
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Agreed it completely depends on the relationship of the original manufacturer and the private labeling company. Normally "private labeling", although not defined in the regulation, generally refers a company only applying their brand to the device but not assuming any specification developer or manufacturing activities.

Domestic distributors (company B) are not required to register with the FDA. A product may be private labeled for a domestic distributor with "Manufactured For" Or "Distributed By" associated with their name. The FDA does not currently require that the manufacturer name (Company A) also appear on the device labeling. In this instance the only listing in FURLS describing this relationship will be the inclusion of the proprietary name of the distributor (Company B) under the manfacturer's (Company A) listing. Company B, solely acting as a domestic distributor, has no listing requirements of their own specifically in relation to the private labeled device in this instance. If the original question was in relation to this type of arrangement, then the answer is there is no listing requirements.
Original Message:
Sent: 23-Aug-2022 04:45
From: Richard Vincins
Subject: Private labels registration

Hello Anon,

No, I am not confusing the US FDA requirements with other regulatory regions.  Just as in the United States as other regions, whosever name is listed as the "Manufacturer" on the device labelling is considered the legal manufacturer, Manufacturer, regulatory responsible - whichever terminology you want to use.  However, unlike in other regions, US FDA does allow the designation of Manufactured By and Manufactured For.  This does give more flexibility for private labellers distributing product in the United States.  Also note there is no such terminology as "private labeller" in the United States regulations.

I disagree with the Medical Device Listing you are stating, because it clearly depends on the relationship of the original manufacturer and the private labelling company.  And what name is listed on the final device labelling.  If Company A the original manufacturer is NOT going to take the regulatory responsibility, then indeed Company B must list the medical device under their name  (and there should be agreements in place).  Please explain how in your example the owner of the 510(k), the original manufacturer, would list another product which is being sold, labelled, and managed by Company B.  In your example, this would be a Manufacturer/Contract Manufacturer relationship and so the original company as the "contract manufacturer" would list the products they are making for Company B.  This same process holds true for "virtual manufacturers" whose name is on the labelling, but the product is being made by another company, a contract manufacturer, ... they would also need to list the medical device they are making for another company.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 17-Aug-2022 10:59
From: Joy Frestedt
Subject: Private labels registration

Yes, in general, each private label should be registered.

Sent from my iPhone


Original Message:
Sent: 8/16/2022 1:40:00 PM
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!

Hi Anon

Both names have to be listed. 

For more info, see the FAQ:  https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements#brand

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

Original Message:
Sent: 17-Oct-2022 13:51
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi,

I have a follow-up question to my inquiry above. If the same company manufactures and sells both the original brand name and the private label name (for that brand), does that company have to list and register both names? Or can they just register the original brand name since they have the same 510K and they are both under the same manufacture?
Original Message:
Sent: 24-Aug-2022 09:33
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Agreed it completely depends on the relationship of the original manufacturer and the private labeling company. Normally "private labeling", although not defined in the regulation, generally refers a company only applying their brand to the device but not assuming any specification developer or manufacturing activities.

Domestic distributors (company B) are not required to register with the FDA. A product may be private labeled for a domestic distributor with "Manufactured For" Or "Distributed By" associated with their name. The FDA does not currently require that the manufacturer name (Company A) also appear on the device labeling. In this instance the only listing in FURLS describing this relationship will be the inclusion of the proprietary name of the distributor (Company B) under the manfacturer's (Company A) listing. Company B, solely acting as a domestic distributor, has no listing requirements of their own specifically in relation to the private labeled device in this instance. If the original question was in relation to this type of arrangement, then the answer is there is no listing requirements.
Original Message:
Sent: 23-Aug-2022 04:45
From: Richard Vincins
Subject: Private labels registration

Hello Anon,

No, I am not confusing the US FDA requirements with other regulatory regions.  Just as in the United States as other regions, whosever name is listed as the "Manufacturer" on the device labelling is considered the legal manufacturer, Manufacturer, regulatory responsible - whichever terminology you want to use.  However, unlike in other regions, US FDA does allow the designation of Manufactured By and Manufactured For.  This does give more flexibility for private labellers distributing product in the United States.  Also note there is no such terminology as "private labeller" in the United States regulations.

I disagree with the Medical Device Listing you are stating, because it clearly depends on the relationship of the original manufacturer and the private labelling company.  And what name is listed on the final device labelling.  If Company A the original manufacturer is NOT going to take the regulatory responsibility, then indeed Company B must list the medical device under their name  (and there should be agreements in place).  Please explain how in your example the owner of the 510(k), the original manufacturer, would list another product which is being sold, labelled, and managed by Company B.  In your example, this would be a Manufacturer/Contract Manufacturer relationship and so the original company as the "contract manufacturer" would list the products they are making for Company B.  This same process holds true for "virtual manufacturers" whose name is on the labelling, but the product is being made by another company, a contract manufacturer, ... they would also need to list the medical device they are making for another company.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 17-Aug-2022 10:59
From: Joy Frestedt
Subject: Private labels registration

Yes, in general, each private label should be registered.

Sent from my iPhone


Original Message:
Sent: 8/16/2022 1:40:00 PM
From: Anonymous Member
Subject: Private labels registration

This message was posted by a user wishing to remain anonymous

Hi all,

I am fairly new to the regulatory world. I have a question regarding the registration of private labels for Class I and Class II devices. Do these private labels need to be registered in the FURLS site? The original label/brands are all registered and are approved through the PMA process so I am not sure if the private labels should be registered as well.

I hope someone can answer me. Thank you!