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  • 1.  Artificial intelligence software

    Posted 28-Jan-2019 05:11
    Hi,
     
    For FDA clearance through a 510(k) or Denovo for such devices , is it necessary /beneficial to enrol in the FDA precertification program  ?
     
    I have visited the earlier discussion forum on this topic and understand the applicable guidances for FDA. Which are the guidelines applicable for CE marking?
     
    We would eventually be hiring consultants for advice and submission. Could you provide me some good references?
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Associate

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    E  rpillay@ellex.com
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  • 2.  RE: Artificial intelligence software

    Posted 29-Jan-2019 13:40
    It is certainly not necessary. It could be beneficial, depending on your exact circumstances. If you have great confidence in your QS, particularly around software, it could be a useful way to be able to make routine changes. For the review of the initial device design, probably less so, though there may well be specific documents that are not requested in the course of the review. On the flip side, if your software QS is still a "work in progress" it could be a bit of a risk if you don't get "precertified" after you try.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 3.  RE: Artificial intelligence software

    Posted 31-Jan-2019 08:23
    Take a look at Bradley Merrill Thompson https://www.linkedin.com/in/bradleymerrillthompson with www.ebgadvisors.com. He's one of the top experts in this area and is frequently quoted by various news outlets regarding new developments in the digital health regulations.

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    Michael Zagorski RAC
    Pittsburgh PA
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    Original Message


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