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  • 1.  SaMD complaints and feedback

    This message was posted by a user wishing to remain anonymous
    Posted 09-Dec-2021 23:42
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Hope everyone is well! I had a question regarding complaint/feedback handling for SaMDs. Our product is a software that is not approved yet (we are tracking for submission early Q2 next year) - do we need a complaint handling procedure as of right now? 

    My reasoning is that when I think of a complaint handling procedure, I think of an approved product with requirements complying to 21 CFR 820.198/803. I do plan on writing the procedure, just wondering about the urgency.

    Thanks!


  • 2.  RE: SaMD complaints and feedback

    Posted 10-Dec-2021 02:48
    Hello Anon,

    You would only need a customer feedback/complaint handling process once the product is cleared/approved/registered for market and being used according to intended use.  So simple answer, no you do not need a procedure right now.  However, if the SaMD is used in clinical trials, usability testing, or any other type of pre-launch aspects, you may want to consider having the process already defined as a place to put feedback.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: SaMD complaints and feedback

    Posted 10-Dec-2021 07:21

    Hi –

     

    Your Software Development Plan must include a section on maintenance, and that would include how you'll handle defects, complaints, or any other issues with your software.

     

    Hope that helps.

     

    Rhonda Johnston | Senior Manager Design Quality Assurance
    rhonda.johnston@smith-nephew.com
    Office: +1.412.683.3844 
    Mobile: +1.412.863.0287
    www.smith-nephew.com

     




    Original Message


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