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  • 1.  Software as a Medical Device

    Posted 22-Sep-2018 09:58
    HI,
    Does anyone have experience with submitting a 510K for digital algorithms that will be used to aid in treatment decisions. The software is cloud based so i am looking for guidance on accepted software architecture , validation and cyber security...


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    Patricia Carrigan
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  • 2.  RE: Software as a Medical Device

    Posted 23-Sep-2018 07:51
    Hello Patricia, 

    did you consider the IEC 82304-1 standard (    Health software - Part 1: General requirements for product safety, FR  Recognition Number 13-97)?
    I recently did compile a EU Tech Doc for a medical app and did find the standard very useful, especially for the aspects of IT SECURITY. 



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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 3.  RE: Software as a Medical Device

    Posted 23-Sep-2018 16:04
    Dear Patricia,

    There are several seminal guidance documents published by the FDA that you will find very useful for a  510(k) submission for software of this kind.

    These are:
    1) Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005
    2) "General Principles of Software Validation; Final Guidance for Industry and FDA Staff'" issued on January 11, 2002
    "Content of Pre-market Submissions for Management of Cybersecurity in Medical Devices" Guidance for Industry and Food and
    3) Drug Administration Staff , issued October 2, 2014 
    4) "Postmarket Management of Cybersecurity in Medical Devices" Guidance for Industry and Food and Drug Administration Staff. Document issued on December 28, 2016.

    If this is a clinical decision making tool for aiding health care providers, such as primary care physicians in triage of patients with a specific chronic disease or its co-morbidity there are some very recent FDA informational pages such as:

    Global Approach to Software as a Medical Device:
    Global Approach to Software as a Medical Device Software as a Medical Device  
    and the draft guidance " Clinical and Patient Decision Support Software" Draft Guidance for Industry and Food and Drug Administration Staff
    Draft Document issued on: December 8, 2017. 

    This last document has painted a much more defined picture of how decision support software can be considered from a Risk Management point of view.  A pre-submission might also be very useful to get a sense of the sample size for a validation study and the sensitivity/specificity the FDA branch would require for your device.

    I would be happy to speak with you further regarding your question.

    Best regards,

    Anne Edwards, MA
    PENTAX Medical
    Montvale, NJ
    551-207-4381

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    Anne Edwards
    Project Manager Regulatory Affairs
    Ho Ho Kus NJ
    United States
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    Original Message


  • 4.  RE: Software as a Medical Device

    Posted 24-Sep-2018 11:22
    Patricia, we have a gentleman by the name of Greg Spar who does this full time.    Mark DuVal   You can find his bio on our website at   Greg Spar | DuVal & Associates, PA | Drug, Device, & Food Lawyers and Regulatory Affairs Consultants
    Duvalfdalaw remove preview
    Greg Spar | DuVal & Associates, PA | Drug, Device, & Food Lawyers and Regulatory Affairs Consultants
    DuVal & Associates is a boutique law firm located in Minneapolis, Minnesota. We offer game-changing guidance for achieving successful outcomes in highly-regulated markets. Our clientele includes companies that manufacture and/or market pharmaceuticals, medical devices, biologics, nutritional/dietary supplements and foods.
    View this on Duvalfdalaw >


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    Mark DuVal FRAPS, JD
    President & CEO
    Minneapolis MN
    United States
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    Original Message


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