Hello Maria,
In the United States this is possible, along with what Anne said, make sure each entity has their establishment properly registered in the United States, i.e. Contract Manufacturer, Manufacturer, Specification Developer, etc. Also make sure the products which are sold in the United States are listed properly on the Medical Device Listing according to their own Brand Names linking back to the regulation number/Product Code or a 510(k)/PMA number. Both entities would be responsible for registration and listing depending on the role they are in, such as a Contract Manufacturer (Company B), and then the Manufacturer (Company A) in this scenario. If you reference 21 CFR 801 there is the wording for how it can be listed on the labelling, such as Manufactured For or Distributed By.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 19-Dec-2023 23:57
From: Anne LeBlanc
Subject: Private label for IVD devices in USA
Dear Maria
Yes, this is possible. The label only needs to show one address, with that clarifying statement about your role.
https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
The manufacturer (B) includes all of the device brand names in their listing. (The system gives them the option to mark the private label brand names confidential if they/you want the relationship visible only to FDA and not published for everyone to see.)
https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements#brand
The US company C that imports the device will also be registered, but doesn't have to be identified on the label.
https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
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Anne LeBlanc
United States
Original Message:
Sent: 19-Dec-2023 07:15
From: Anonymous Member
Subject: Private label for IVD devices in USA
This message was posted by a user wishing to remain anonymous
Dear community colleagues,
I would like to ask for your advise for the following scenario:
Manufacturer A based in Europe contracts manufacturer B based in Canada to pack/label manufacturer's B IVD devices into Manufacturer A brand (private label) to be sold exclusively in USA. Manufacturer B has its own branded products registered in US FDA and sold under manufacturer's B brand in US.
Question:
- Is this scenario possible?
- How would the label look like? (Is it possible to have "Manufactured for A" - with name and address of A only, even if the address is an EU address? Would the US distributor need to be on the label as well?)
- Who would be responsible for registration / listing of the devices? Manufacturer A or B? (Or A could list using B's PMA or 510k numbers?)
Thanks and Regards,
Maria