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  • 1.  UDI-PI for standalone software not sold as packaged

    This message was posted by a user wishing to remain anonymous
    Posted 02-Sep-2020 08:51
    This message was posted by a user wishing to remain anonymous

    UDI-PI for standalone software not sold as packaged
    Is unique UDI is mandatory for each software installed? Or just a PI with version number and date of mfg is enough? which may be common for many can be sold.


  • 2.  RE: UDI-PI for standalone software not sold as packaged

    Posted 02-Sep-2020 11:46
    Hi,

    As per FDA's guidance (https://www.fda.gov/media/89275/download) - All stand-alone software, whether packaged or unpackaged (e .g., software downloaded from
    a website), must provide its UDI through either or both of the following: (1) An easily readable plain-text statement displayed whenever the software is started; (2) An easily
    readable plain-text statement displayed through a menu command (e.g., an "About..." menu command).

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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    Original Message


  • 3.  RE: UDI-PI for standalone software not sold as packaged

    Posted 02-Sep-2020 12:41
    Edited by Kevin Randall 02-Sep-2020 12:41
    Each replicate install of standalone software does not require a unique UDI in the U.S. or EU.  Specifically,


    • For the FDA, refer to 21 CFR 801.50 from which we know that stand-alone software not distributed in packaged form (e.g., software downloaded digitally) is deemed to meet the UDI labeling requirements if it conveys the version number in its PI (which will be the same for each replicate install of the same version).  We also know this from FDA's fundamental definition of PI reminding us that the PI may be formulated based on a "lot or batch" of the device, which in turn by formal definition includes multiple units (i.e., installs) of software that all have the same version.

    • For the EU MDR, refer to Annex VI Part C subsection 6.5 reminding us that the UDI for standalone software is to be assigned at the system level (i.e., at the software version level) of the software rather than the installation level.  Similar to the U.S., the UDI-PI may be formulated based on the software version (which will be the same for replicate installs of the same version).


    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    Note that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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