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Identifying the FDA "Device Labeler" for UDI on private label devices

  • 1.  Identifying the FDA "Device Labeler" for UDI on private label devices

    This message was posted by a user wishing to remain anonymous
    Posted 3 days ago
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I am sorting out our company's procedure for identifying the FDA "device labeler" for purposes of UDI assignment and the various 3rd party options are not clear. Currently the SOP has a table of accountabilities and responsibilities between our company and the other party with whom we're working, based on arrangement, so a number of the options are specified when clear (e.g., if we are on the label only in a distributor capacity, the 3rd party assigns the UDI), but when there is a combination of possible responsibility for "caus[ing] a label to be applied to a device, or [causing] 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 SOP just indicates that both parties are responsible and accountable for figuring it out.

    The particular question of the day is for private labeled devices. The device is designed by Company Them, but it is labeled as a Company Us product, using our trademark name for the device. Company Them is listed as the manufacturer on the label, but all other references are to Company Us.

    My interpretation of this, looking at the FDA regulations and guidance alongside the issuing agency's terminology of Brand Owner, is that we can't delegate the responsibility to assign the UDI if it is branded as Our Product. They aren't legally able to cause a device to be labeled with our company trademark information - only we can cause such a label to be placed on a device.

    To put this in non-healthcare terms, if Coca Cola contracts with Sprecher to make and label Coke Sarsaparilla, and it is in distribution under Coca Cola, it is labeled under the Coca Cola Brand, which makes them the Brand Owner of the GS1 GTIN.

    Does anyone see an appropriate scenario where the "Company Us UsDevice", manufactured by Company Them, is not our responsibility for UDI and GUDID? This issue then also spills over into Device Listing questions. Currently, Company Them is listed as the Manufacturer, Company Us is listed as the Complaint File Establishment, and Company Us-Swiss Entity is listed as the Foreign Exporter.

    Has anyone else had similar issues? I'd love to hear others' experiences.