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  • 1.  FDA UDI-- Carton Graphics & Labeling

    This message was posted by a user wishing to remain anonymous
    Posted 09-Mar-2017 13:26
    This message was posted by a user wishing to remain anonymous

    If the device does not require a package DI, do updates to carton graphics (such as adding medical device symbols or product images) require a new device identifier? The change is not considered a new version or model of the device. Carton graphics or labeling aren't specifically mentioned as a new DI trigger in the GUDID Data Elements Reference Table nor seem to be mentioned in the regulations...


  • 2.  RE: FDA UDI-- Carton Graphics & Labeling

    Posted 10-Mar-2017 09:05
    Hi,

    Please clarify if you are using the package and carton as the same thing.

    It sounds like there is no requirement for the DI and therefore the DI would not need to change.  The only thing I would check is if the symbols being added are listed as attributes for that DI in the GUDID.  If, for instance, you are adding a temperature range and had not listed this in the GUDID, you would need to add this.  Adding or editing storage and handling conditions do not trigger new DI's.

    Regards,

    ------------------------------
    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
    ------------------------------

    Original Message


  • 3.  RE: FDA UDI-- Carton Graphics & Labeling

    This message was posted by a user wishing to remain anonymous
    Posted 13-Mar-2017 10:04
    This message was posted by a user wishing to remain anonymous

    John-- Thank you for your opinion. Yes, I am using the terms "carton" and "package" interchangeably. The symbol being added is not listed as an attribute in the GUIDID. 
    Original Message


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