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  • 1.  UDI: DI Record Publish Dates and updated DI's

    Posted 27-May-2016 14:03

    Hi everyone,

    I'm expecting this to be a simple confirmatory question, but I've learned in my career that these are often the hardest questions to answer.

    In the GUDID, there's a value called "DI Record Publish Date".  I know that changes to most values in the GUDID would result in a new UDI, but there are a few that could be actually updated.  Is it safe to assume that value is updated when the UDI record is updated?  There's no indication either way (that I found) in the UDI guidance, so I just want to confirm.

    Thanks!

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    Jeanette Murray RAC, MS
    Hillsborough NJ
    United States
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  • 2.  RE: UDI: DI Record Publish Dates and updated DI's

    Posted 27-May-2016 14:29

    Your intuition is correct, your assumption about the "DI Record Publish Date" is not correct.

    The fields in GUDID describe attributes of the device. Interestingly the GUDID fields also have attributes (meta-attributes). Some fields are fixed and cannot change. Some fields are fixed, cannot change, and if the associated device attribute changes then the labeler must create a new DI record. Some GUDID fields are changeable even if the DI record is public.

    The DI Record Publish Date is a fixed field. It determines whether or not the DI Record is public, i.e., whether or not it is available from Access GUDID.

    If one were to update a changeable field, it would not affect whether or not the DI Record is available from Access GUDID. Thus, the DI Record Publish Date field is fixed.

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 3.  RE: UDI: DI Record Publish Dates and updated DI's

    Posted 28-May-2016 13:42

    Hi, Jeanette,

    At the bottom of FDA's Global UDI Database page are a list of resources.  Click on and download "GUDID Data Elements Reference Table - April 14, 2016".  This has all the edit rules and Data Entry Notes.

    Global UDI Database (GUDID)

    Fda remove preview
    Global UDI Database (GUDID)
    The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. The public can access information contained in the GUDID through AccessGUDID .
    View this on Fda >

    The DI Record Publish Date determines when the Grace Period starts. For the DI Record Publish Date you can make changes to that cell anytime until after the grace period date of publishing the record.  If you put today's date you have until the grace period is up to make changes for the next 30 days, starting tomorrow. (It says 7 days but they are currently giving us 30. That extended grace period could go back to 7 days at any time, so don't count on 30.)

    If you set the date in the future, you can go back in and change it at any time up until 30 days after that future date because the record has not published yet.  You can set it for Sept. 24, 2016 and then go back in on August 24th and change it to August 25th.  You will the still be able to make changes to any data element in that record for the next 30 days during the Grace Period.  You will not be able to change it after the Grace Period.

    Read the Data Entry Notes in the GUDID Data Elements Reference Table - April 14, 2016 if you are still unclear.

    Regards,

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    John Minier, RAC
    Sr. Manager, Corporate Regulatory Affairs
    Integra LifeSciences
    Plainsboro, NJ
    United States

    Original Message