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  • 1.  Device Listing of Private Label Device

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2023 14:47
    This message was posted by a user wishing to remain anonymous

    We are purchasing a private label device from the OEM.  The device is their design and they manufacture it with our brand.  Do we have to list the device with FDA or does the OEM list it?



  • 2.  RE: Device Listing of Private Label Device

    Posted 01-Jun-2023 14:51

    If you are purchasing a private label device from an original equipment manufacturer (OEM), the responsibility for listing the device with the FDA typically rests with the manufacturer, which in this case would be the OEM.

    Under the FDA regulations, the manufacturer of a medical device is generally required to list the device with the FDA. The device listing process involves providing information about the device, its intended use, and the manufacturing facility to the FDA. This requirement applies to both OEMs and private label distributors.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Device Listing of Private Label Device

    Posted 02-Jun-2023 07:46

    Hi, 

    This link may help. 

    https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee#:~:text=Establishments%20that%20are%20involved%20in,register%20annually%20with%20the%20FDA.



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    Suraj Maharjan
    Sr. Regulatory Affairs Specialist
    Windham NH
    United States
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    Original Message


  • 4.  RE: Device Listing of Private Label Device

    Posted 04-Jun-2023 03:17

    Hello Anon,

    There can be a little more information needed, particularly how the finished product is going to be labelled.  If the product is going to be sold in the United States under your company name, with your product name, with your branding, with your logo, etc., then this would be a Manufacturer / Contract Manufacturer relationship.  If the product is sold in your company name, with your name on the label, then you would be the Manufacturer.  This product would be listed in the Medical Device Listing under your company name and trade name, but then you would indicate there is a Contract Manufacturer - the OEM company - who is actually making the device.  The label would then say, "Manufactured For: Your company" indicating there is another another company making the device.  Then in the FURLS system it would show in the device listing which product you are selling/placing on the market in the US and relationship to the OEM or Contract Manufacturer.  So when there is a OEM/private label relationship, both companies may end up needing establishment registration and understanding of who lists the product.  As you indicate they are going to be manufacturing 'our brand' it seems like this is the scenario you would need to put in place.



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


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