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  • 1.  UDI for Private Label Devices

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2018 12:31
    This message was posted by a user wishing to remain anonymous

    For private label devices, it seems that the UDI should be owned by the original equipment manufacturer (oem).  I base this off the assumption that whoever holds the design of the device should own the UDI, but I am not certain. Can anyone help me understand?


  • 2.  RE: UDI for Private Label Devices

    Posted 13-Jul-2018 09:05
    Hello,

    Under the FDA's UDI Rule, the "labeler" is responsible for ensuring UDI labeling requirements are met.  The labeler is typically the entity whose name is on the device labeling, regardless of whether a different entity originally manufactured the device.  There is more information in the FDA document "Unique Device Identifier System: Frequently Asked Questions, Vol.1" (see B.1. on page 14) found on the FDA website: UDI Resources 

    I hope this was helpful.

    Regards,

    ------------------------------
    Camille Thorpe, RAC (Canada)
    Mississauga ON
    Canada
    ------------------------------

    Original Message


  • 3.  RE: UDI for Private Label Devices

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jul-2018 09:59
    This message was posted by a user wishing to remain anonymous

    I thought the same thing, but FDA has made it clear that the labeler is responsible for UDI.  That said, the company that I used to work for negotiated with multiple OEMs (based on the fact that they are the design authorities for the products) and was able to get the OEMs to agree to being responsible for UDI.
    Original Message


  • 4.  RE: UDI for Private Label Devices

    Posted 13-Jul-2018 10:23
    As stated in the previous responses, the "labeler" is responsible for the UDI. The FDA definition of "labeler" is:
    "any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler."

    This does not necessarily mean the physical application of the label to the device package. Being responsible for the UDI means assigning the UDI to the product with their company prefix and having the data submitted to the GUDID. All of these "functions" can be outsourced or assigned to the OEM through contractual agreement, but ultimately it is the "labeler".

    ------------------------------
    Lena Cordie
    Victoria MN
    United States
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    Original Message


  • 5.  RE: UDI for Private Label Devices

    Posted 16-Jul-2018 09:25
    If you wish to outsource the UDI responsibilities to the OEM that would be easiest.  They may want to include their own GTIN number so it is identified when scanned as their product.  You can however purchase your GTIN and have the OEM use that (preferred for you).

    If you only have one or two products, it is easy enough to enter the data in GUDID.  Make sure you know what standard & quality of barcode the OEM has.

    ------------------------------
    Valerie Followell
    Consultant
    Skokie IL
    United States
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    Original Message


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