Regulatory Open Forum

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  • 1.  multiple indications of use in the same IFU

    Posted 12-Dec-2023 14:19

    Is it feasible to create a single Instructions for Use (IFU) document that caters to different markets, each with distinct indications of use? For instance: This product is intended for professional use only in Canada and for insurance and employment use only in the United States.



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    Nancy Zwiep
    Regulatory Affairs Manager
    Barrie ON
    Canada
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  • 2.  RE: multiple indications of use in the same IFU

    Posted 13-Dec-2023 06:12

    Hello Nancy,

    It is feasible, though generally frowned upon by regulatory agencies.  The reason being is when having multiple indications in the Instructions for Use (IFU) could lead to other person in different jurisdictions using the product "off label".  If there maybe is some minor differences say in population it might be ok, but getting "acceptance" from regulatory agency would probably be not successful as they are specific on the indications for use.  You would also want to use caution because if this is done and a regulatory agency has an issue with this, due to labelling, could result in a field correction or recall.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: multiple indications of use in the same IFU

    Posted 13-Dec-2023 07:39
    Hello Nancy,

    While it is feasible to create a single Instruction for Use, in your case the better course of action would be to market the product with different SKUs for the different indications.  This would also make post-market surveillance and adverse event reporting much easier as it would seem that the different indications would result in vastly different monitoring/reporting scenarios.  Having different SKUs would also mitigate issues of promotion of off-label uses.

    Regards,
    James




    Original Message


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