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.