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  • 1.  GUDID edit rules

    Posted 20-Oct-2017 16:01
    ​Does anyone have any experience with editing/deleting GUDID records that are published? I'm taking over some of the Regulatory work at my firm and during review I discovered there are published records in GUDID that should not be in GUDID, and published records in GUDID that contain inaccurate information. Can I fix them? And, if so, how?

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    Paul Martin
    Rauland, A Division of AMETEK, Inc.
    Mount Prospect IL
    United States
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  • 2.  RE: GUDID edit rules

    Posted 20-Oct-2017 16:12
    Paul,

    Once a record is published (say, 7 day grace period is over), it is out of your control.  Only FDA can change the attributes published. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 3.  RE: GUDID edit rules

    Posted 21-Oct-2017 10:36
      |   view attached
    Paul,
    You should contact the FDA UDI Help Desk and explain what changes you want to make.  The FDA will determine that either the changes are permitted, or that the changes are such that they now represent a different device, in which case you will need to submit a new DI.  If FDA determines that the changes are permitted (because they don't represent a new device), they can move your record back to the Unpublished DI record state so that you can make the changes.  (The FDA does not make changes themselves.)
     
    I've attached FDA Guidance that provides good information about changing GUDID data after the record has been published (see page 20).  I suggest you review the Guidance first, then contact the FDA UDI Help Desk.

    Regards,
    Laura

    ------------------------------
    Laura Halper PhD
    Consultant
    Halper Group
    Plano TX
    United States
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    Attachment(s)

    pdf
    FDA Guidance - GUDID - Final 6-27-2014.pdf   2.78 MB 1 version
    Original Message


  • 4.  RE: GUDID edit rules

    Posted 21-Oct-2017 11:16
    ​

    Paul,

    A FDA GUDID record has four lifecycle states; Unpublished, Published-Grace-Period, Published, and Discontinued.

    * An Unpublished record is visible only to the owner and can have all attributes changed.

    * A Published-Grace-Period record is visible only to the owner and can have all attributes changed except the Published Date value. The Grace Period lasts 30 days after the Publish Date (the FDA extended the 7 day duration).

    * A Published record is visible to the public on the NLM AccessGUDID website and can have most of the attributes changed, but roughly 16 of the total 64 attributes are fixed. See the GUDID Data Elements Reference Table - March 27, 2017 (XLS - 435KB) on the FDA UDI Resources website for details regarding attribute editing rules.

     Submit a FDA UDI Help Desk Ticket to request FDA intervention to make changes to fixed attributes or to "remove" records from the GUDID. The FDA may return the record to the Unpublished state for you to update the attributes or may require a new DI record be submitted.

    Regards,
    Gary
    gsaner@reedtech.com, www.Reedtech.com 

     



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    Gary Saner
    Sr Mgr Information Solutions Life Sciences
    Reed Technology
    Horsham PA
    United States
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    Original Message


  • 5.  RE: GUDID edit rules

    Posted 21-Oct-2017 20:07
    My understanding is that after the 30 day grace period you can only delete.

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    Valeria Sena-Weltin, M.S., RAC(US)
    Regulatory Affairs Specialist
    Gaithersburg, MD
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    Original Message


  • 6.  RE: GUDID edit rules

    Posted 22-Oct-2017 17:54
    Edited by John Minier 22-Oct-2017 17:59
    The edit rules are different for each data element.  Some can be changed (like prescription use), some cannot, and some can have data added (like a supplement number) but no data deleted or edited, and some say you cannot change but a change does not trigger a new DI.  This last makes no sense but that is what it says in the edit rules table.

    The edit rules table is here:

    https://www.fda.gov/downloads/MedicalDevices/UCM396592.xls

    You may have to copy and paste this.

    And, of course, the 7 day editing of any data element has been unofficially extended to 30 days after publication.  Also any change can be be made in draft or before the publication date as mentioned above.

    The help desk can unpublish items if justified.  They do not guarantee they will do this.  If all else fails, you may have to retire a DI and create a new DI but this will require changing labels and your own database which is a pain.

    PM me if you have difficulty reading the table and we can discuss.

    Best regards,

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


  • 7.  RE: GUDID edit rules

    Posted 23-Oct-2017 10:55
    Using the table that was provided by John, check to see if your field is editable - if so, you can go in and change it  (if you have "Label Entry" access.)  If you do not have label entry access, contact the help desk and request it.

    If you have fields that are not editable, you can edit the data by contacting the the help desk to unpublish the record.

    They will send you a spread sheet to complete to identify the fields you need to be editable and then send you a message when complete. 
    You then go in, edit the fields, save them and their status changes to "published" (but note that the changes are not visible to the public yet) with a 30 day grace period to alter if needed. 
    After 30 days they are then officially published and the public can view them with the changes incorporated.

    The help desk team have been extremely helpful and understanding.   
    Their goal is to have clean data so they will work with you. 
    Their response time has been very, very fast.  

    Dawn Fowler

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    Dawn Fowler
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    Original Message


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