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  • 1.  Combination Product_3.2.R. MAA Dossier Europe - Usability Studies required?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2022 09:41
    This message was posted by a user wishing to remain anonymous

    Hello,

    I plan to submit a drug-led iDDC for a NBOp. Since Usability studies will be part of the NB submission and will be assessed by the Notified Body, I am unsure whether I need to submit the Usability studies also with the MAA dossier (3.2.R.) to EMA.

    Following EMA's Quality Device Guideline I tend to not submit the Usability as part of section 3.2.R.

    Curious to hear your thoughts? ​


  • 2.  RE: Combination Product_3.2.R. MAA Dossier Europe - Usability Studies required?

    Posted 31-Aug-2022 02:12
    Dear Anon,

    I agree with your idea. Since you plan to obtain an NBOp for your iDDC, there is no need to duplicate this information in your medicinal product submission. Simply provide a reference to the NBOp and/or the Summative Human Factors Study Report. This is the way we have consulted our clients in the past and there was never a negative feedback from EMA or a National Competent Authority.

    Best regards
    Beat


    ------------------------------
    Beat U. Steffen, FRAPS
    confinis ag
    Founder & CEO
    Düdingen, 3186
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: Combination Product_3.2.R. MAA Dossier Europe - Usability Studies required?

    Posted 31-Aug-2022 07:28
    Hi Anon,

    Your instincts are correct.  The only time HF information would be provided to 3.2R in the MAA would be in the unusual case where the information reviewed as part of the NBOp did not include/accommodate the actual product, or intended users of the product, as provided covered in the MAA.

    ------------------------------
    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
    ------------------------------

    Original Message


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