Medical device private label question.

[lena0506]

Hello everyone,

We are a foreign manufacturer outside the US. Our product has been 510 (k) cleared.

A U.S. company, Company B, would like to market our product in the United States under their private label. They will use their brand instead of our brand.

I would like to consult whether this arrangement is regulatory compliant. Is Company B the relabeler?

Does Company B need an additional 510(k) submission if they want to delete our brand name and add their brand in the original labeling we submitted to 510(k) before?

Thank you.

 

[Nichole F]

Company B would be the Private Labeler or Private Label Distributor. They can sell under the existing 510(k) providing no significant changes are made to the already-cleared device. Generally, you cannot have the same device on more than one 510(k) unless a significant change has been made.

Company B will still need to comply with applicable FDA regulations such as Facility Registration and device listing. Your Quality Agreement with Company B should clearly outline and designated responsibilities.

 

[lena0506]

Company B would be the Private Labeler or Private Label Distributor. They can sell under the existing 510(k) providing no significant changes are made to the already-cleared device. Generally, you cannot have the same device on more than one 510(k) unless a significant change has been made.

Company B will still need to comply with applicable FDA regulations such as Facility Registration and device listing. Your Quality Agreement with Company B should clearly outline and designated responsibilities.

Thanks for your response.

 

[Haresh]

Company B would be the Private Labeler or Private Label Distributor. They can sell under the existing 510(k) providing no significant changes are made to the already-cleared device. Generally, you cannot have the same device on more than one 510(k) unless a significant change has been made.

Company B will still need to comply with applicable FDA regulations such as Facility Registration and device listing. Your Quality Agreement with Company B should clearly outline and designated responsibilities.

Hi Nichole,

I need your guidance on the below scenario. And I have couple of questions. It would be great if you support in below case.

Suppose, we wish to do the labelling activities at OEM facility (510K owner) with our company name "ABC" (currently acting as initial importer) and our address .And label will includes same product's name as OEM has. UDI will also included as per Company "ABC" UDI .So,complete labelling and packaging activities will be carried out at OEM end per the agreement. The final device label would be phrased with "Manufacturer For ABC Inc."
It would be great if you provides insights on it.
a. Whether company "ABC" will acts as a Relabeler with consideration of above scenario.
b. Is it necessary to have a QMS at Company "ABC" ( say example -document control, purchase control ,UDI and GUDID account management , Management controls, Internal audits, complaint management, MDR reporting)
Note : OEM will take care of Design and Development activities.
c. Is it necessary to have Company ABC logo on the lasermarked parts as OEM has their company logo on the parts which are 510K cleared and OEM drawing includes their logo .
d.Can company "ABC".will do the documentation in consultation with the OEM due to limited resource at company "ABC".
d. If company "ABC" will implement the adequate QMS then will company "ABC" become the "Manufacturer"
e. Is it mandatory to have "OEM name and address" along with the company "ABC" Name and Address.
f. How we can update the additional role of company "ABC" as a Relabeler of device on FURLS database.Just do tick mark in-front of Relabel/repack of device will be suffice to demonstrate role. If any guidance documents or procedure available then please provide to us.

Thanks
Haresh N

 

[Nichole F]

Hi Nichole,

I need your guidance on the below scenario. And I have couple of questions. It would be great if you support in below case.

Suppose, we wish to do the labelling activities at OEM facility (510K owner) with our company name "ABC" (currently acting as initial importer) and our address .And label will includes same product's name as OEM has. UDI will also included as per Company "ABC" UDI .So,complete labelling and packaging activities will be carried out at OEM end per the agreement. The final device label would be phrased with "Manufacturer For ABC Inc."
It would be great if you provides insights on it.
a. Whether company "ABC" will acts as a Relabeler with consideration of above scenario.
b. Is it necessary to have a QMS at Company "ABC" ( say example -document control, purchase control ,UDI and GUDID account management , Management controls, Internal audits, complaint management, MDR reporting)
Note : OEM will take care of Design and Development activities.
c. Is it necessary to have Company ABC logo on the lasermarked parts as OEM has their company logo on the parts which are 510K cleared and OEM drawing includes their logo .
d.Can company "ABC".will do the documentation in consultation with the OEM due to limited resource at company "ABC".
d. If company "ABC" will implement the adequate QMS then will company "ABC" become the "Manufacturer"
e. Is it mandatory to have "OEM name and address" along with the company "ABC" Name and Address.
f. How we can update the additional role of company "ABC" as a Relabeler of device on FURLS database.Just do tick mark in-front of Relabel/repack of device will be suffice to demonstrate role. If any guidance documents or procedure available then please provide to us.

Thanks
Haresh N

If all Company ABC is doing is distributing the device under their name, the device should be labelled "Distributed By ABC" with ABC's name and address. Manufactured For applies with Company ABC is the legal manufacturer, meaning they own the design, 510(k), etc. and utilize the OEM as a contract manufacturer.

1. In your scenario, ABC is a Private Labeler.
2. Company ABC needs to fulfill the requirements of the initial importer (and possibly US Agent if they are also fulfilling that role). The requirements of part 820 do not apply to Distributors of medical devices. You should have a contract in place with the OEM to designate roles and responsibilities. You will likely need to have processes for things like complaint files, storage and handling, etc. This depends on how the device is labelled though. If Company ABC is acting as a relabeler, Company ABC is assuming manufacturing responsibilities and needs a QMS in compliance with 21 CFR §820 (and ISO 13485:2016 since FDA has integrated that by reference)
3. If the device is intended to be reused, direct marking for UDI may apply. There is no requirement for any logos to be on the device so that is between you and the OEM.
4. Can you please explain what you mean by "Can company 'ABC" will do the documentation in consultation with the OEM due to limited resource at company 'ABC'"? Limited resources is never an excuse for not fulfilling requirements. If you do not have the resources or expertise in-house it is always expected that you still fulfill the requirements and that may be hiring an consultant. What documentation are you referring to?
5. No; Company ABC is only the manufacturer if they make the device or contract the manufacturing of the device under their design and specifications to another entity.
6. For the US, it is acceptable to have "Distributed by Company ABC" assuming the OEM approves the label.
7. Company ABC is only the relabeler if Company ABC is the entity physically alters the label (e.g., removes or covers OEM's label with Company ABC's label).

Just a suggestion, DICE (FDA's device advice) is super helpful and last time I contacted them (granted it was several years ago) were quick to respond. While they cannot provide direct answers on what a company should do, they can certainly clarify FDA's thinking on the application of the regulations. They will likely be very helpful with straight from the source advice about what the role of Company ABC is. Their email and phone number are available on FDA's website.

 

[Haresh]

If all Company ABC is doing is distributing the device under their name, the device should be labelled "Distributed By ABC" with ABC's name and address. Manufactured For applies with Company ABC is the legal manufacturer, meaning they own the design, 510(k), etc. and utilize the OEM as a contract manufacturer.

1. In your scenario, ABC is a Private Labeler.
2. Company ABC needs to fulfill the requirements of the initial importer (and possibly US Agent if they are also fulfilling that role). The requirements of part 820 do not apply to Distributors of medical devices. You should have a contract in place with the OEM to designate roles and responsibilities. You will likely need to have processes for things like complaint files, storage and handling, etc. This depends on how the device is labelled though. If Company ABC is acting as a relabeler, Company ABC is assuming manufacturing responsibilities and needs a QMS in compliance with 21 CFR §820 (and ISO 13485:2016 since FDA has integrated that by reference)
3. If the device is intended to be reused, direct marking for UDI may apply. There is no requirement for any logos to be on the device so that is between you and the OEM.
4. Can you please explain what you mean by "Can company 'ABC" will do the documentation in consultation with the OEM due to limited resource at company 'ABC'"? Limited resources is never an excuse for not fulfilling requirements. If you do not have the resources or expertise in-house it is always expected that you still fulfill the requirements and that may be hiring an consultant. What documentation are you referring to?
5. No; Company ABC is only the manufacturer if they make the device or contract the manufacturing of the device under their design and specifications to another entity.
6. For the US, it is acceptable to have "Distributed by Company ABC" assuming the OEM approves the label.
7. Company ABC is only the relabeler if Company ABC is the entity physically alters the label (e.g., removes or covers OEM's label with Company ABC's label).

Just a suggestion, DICE (FDA's device advice) is super helpful and last time I contacted them (granted it was several years ago) were quick to respond. While they cannot provide direct answers on what a company should do, they can certainly clarify FDA's thinking on the application of the regulations. They will likely be very helpful with straight from the source advice about what the role of Company ABC is. Their email and phone number are available on FDA's website.

Thank you Nicole for detailed information.