Regulatory Open Forum

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  • 1.  Recall Decision Tree

    Posted 23-Nov-2017 14:04
    ​Does anyone have a decision tree, flow chart, or other tool that you use to determine when a recall is necessary that you'd be willing to share?  

    Bonus points for a tool that covers multiple countries :)

    Thanks!

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
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  • 2.  RE: Recall Decision Tree

    Posted 28-Nov-2017 10:08
    Not really a flow chart (though a basic one is included on p 17) and very US-centric, but we use this AAMI document, which has incredibly good illustrative examples.

    http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/WhitePaper/Postmarket_Risk_Management_120816.pdf

    There was significant FDA participation in creating this, and it has been my recent experience that most folks in OC seem willing to listen to an approach based on this paradigm.

    US only, I'm afraid. Though I think the risk-benefit construct will serve other markets as well, since most of them require recalls far more based on risks than the "violation" orientation of the US.

    g-

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    Ginger Glaser RAC
    Chief Technical Officer
    MN
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    Original Message


  • 3.  RE: Recall Decision Tree

    Posted 29-Nov-2017 08:40
    Health Canada's "Guide to Recall of Medical Devices (GUI-0054) is very comprehensive and informative. It contains flowcharts and descriptions that when slightly modified (e.g. definitions, timelines) could probably serve other regions.
    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html#aE-p1-1

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    Michael Zagorski RAC
    Pittsburgh PA
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    Original Message


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