Regulatory Open Forum

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  • 1.  Expected life of the device

    Posted 17-Sep-2019 13:39
    Hi All, 

    Can someone point me to the FDA regulations related to device life / expected useful life? 

    Kind regards,

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    Justin Osmond MA
    Sr. Regulatory Affairs Specialist
    Ottawa ON
    Canada
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  • 2.  RE: Expected life of the device

    Posted 18-Sep-2019 00:14
    Any particular regulations?  There's a definition at 21 CFR 803.3 (f).​

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Expected life of the device

    Posted 18-Sep-2019 03:45
    There are some explanations of device life in different FDA guidance documents, couple places in the regulations, but as far as I know there is not a succinct definition for device life.  Personally, I can see this is not defined because device life can vary quite a lot depending on device type.  And in fact there are terms such as device life, usable life, serviceable life, shelf life, expiration date; these all need to be defined by the company.  Depending on your device type the device life should be clearly described including justification for device life, according to different parameters such a usable life an/dor shelf life.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Expected life of the device

    Posted 18-Sep-2019 13:11
    There is a defined term in IEC 60601-1, ed. 3.1 which is in clause 3.28 for EXPECTED SERVICE LIFE which is "time period specified by the MANUFACTURER during which the ME EQUIPMENT or ME SYSTEM is expected to remain safe for use (i.e. maintain BASIC SAFETY and ESSENTIAL PERFORMANCE)."

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
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    Original Message


  • 5.  RE: Expected life of the device

    Posted 18-Sep-2019 13:22
    [See my previous reply]

    So, if your device is an electro-medical device that meets the scope, clause 1, of IEC 60601-1, ed. 3.1 than you can use this definition I mentioned just previously for EXPECTED SERVICE LIFE of clause 3.28.  In clause 1 you do need to make sure you also meet either the definition of MEDICAL ELECTRICAL EQUIPMENT of clause 3.63 or MEDICAL ELECTRICAL SYSTEM of clause 3.64 to fall under the scope of the standard.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 6.  RE: Expected life of the device

    Posted 19-Sep-2019 07:37

    Depending on the type of device, Cybersecurity needs to also be factored into this discussion.  With more and more devices being build with software, whether it's commercial off the shelf or open source, there needs to be consideration for how to manage devices when the software that is part of the device "expires".  For example, there are still devices in use that run the Windows XP operating system, which Microsoft ended support for in 2014.  This means security patches are no longer provided for the operating system, so if a new vulnerability comes up that could present a patient safety risk, it cannot be fixed through a security patch and based on the 2016 Post Market Cybersecurity Guidance from FDA it could be considered a recall

     

    The term "end of support" is defined in the FDA's 2018 draft guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical devices", with the expectation that support and lifetime planning is done for Cybersecurity and shared with customers. 

     

    Just another element to consider if building and managing devices with software. 



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    Colin Morgan
    Managing Director
    colinmorgan@apraciti.com
    United States
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    Original Message


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