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  • 1.  MDD change notification

    This message was posted by a user wishing to remain anonymous
    Posted 05-Aug-2022 10:36
    This message was posted by a user wishing to remain anonymous

    Hi,

    I have a question related to labeling update. The IFU is going to be revised to remove a warning and include information that would say the device is MR Safe. Although, this is a retrospective update to the labeling but I suppose this would trigger a MDD change notification to a class III implantable device containing animal tissue. What do you think?

    If you agree that it would trigger a MDD notification, what should be the documentation requirement apart from the redlined/clean copy of the labeling. 

    Please let me know your thoughts. 

    Thanks!


  • 2.  RE: MDD change notification

    Posted 09-Aug-2022 09:16
    Is the change related to CAPA?

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 3.  RE: MDD change notification

    This message was posted by a user wishing to remain anonymous
    Posted 11-Aug-2022 09:35
    This message was posted by a user wishing to remain anonymous

    No- it is not.
    Original Message


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