Regulatory Open Forum

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  • 1.  Lot Sterilization

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2019 12:15
    This message was posted by a user wishing to remain anonymous

    Is a sterilization validation report (or lot sterilization report) required for Ethics Committee/Competent Authority review for a small clinical study using a Class III medical device, or would a sterilization plan suffice.


  • 2.  RE: Lot Sterilization

    This message was posted by a user wishing to remain anonymous
    Posted 24-Apr-2019 12:10
    This message was posted by a user wishing to remain anonymous

    Hello Anon,

    I think it depends on what country you're talking about, as well as what kind of sterilization method you're using (i.e., how established it is). In several countries, including US, Canada, and several countries in Europe, we were able to initiate clinical trials for a class III device using product that was sterilized under batch release (not yet validated). We did provide data showing our sterilization process was robust and detailed how we performed the batch release, and we also submitted representative batch release reports. However, other countries (e.g., Germany) may not approve the trial until full sterilization validation has been conducted, no matter what rationale you provide. 

    (Another) Anon