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  • 1.  FDA Definition of Timely Software Updates

    Posted 11-Jun-2021 13:26
    Hello - 

    Does anyone have feedback on how FDA views timely software updates in regards to software contained in medical devices?

    Thank you, 

    Meghan Moore

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    Meghan Moore
    Regulatory Affairs Specialist
    Andover MN
    United States
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  • 2.  RE: FDA Definition of Timely Software Updates

    Posted 14-Jun-2021 08:20
    Edited by Richard Vincins 14-Jun-2021 08:23
    Hello Meghan,

    I am not sure you will find any information on software updates and when these should be done - primarily because there are many reasons why a software contained in a medical device would be updated.  If you look at IEC 62304 and other SDLC guidance documents there is the operation and maintenance phase where management of changes are made.  When you make reference to FDA viewing timely updates, I am assuming you are talking about complaints and/or adverse events.  There is no time defined as this really depends on the risk assessment of the issue, what impact on patient safety, type of defect, etc.  What I would recommend is be very careful about a "software update" as this can be construed as a market correction under 21 CFR 806.  Software updates should be clearly described, what impact they have, and implemented as appropriate to the issue observed.

    Edit: And sorry for being so "it depends" but unless the specific software issue is described, type of device, situation, hazards, effects, it is really hard to give a definitive answer.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: FDA Definition of Timely Software Updates

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2021 09:23
    This message was posted by a user wishing to remain anonymous

    Hi Regex Team,
        Would this be considered as Different in the context of ME MDR reference to 'state-of-the-art'. Would a Annual review of the Software to keep it up-to-date require a Software upgrade depending on the complexity and severity of the known anomalies in the software?.
    Original Message


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