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  • 1.  Spare parts

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2023 13:41
    This message was posted by a user wishing to remain anonymous

    Hi Experts, 

    What are spare parts of an instrument identified as by the FDA? Are they considered components or accessory?

    Thank you!



  • 2.  RE: Spare parts

    Posted 17-Jun-2023 03:19

    Hello Anon,

    There is no formal definition of spare parts by the US FDA in regulation though there are other descriptions of spare parts, such as in the UDI information.  As an example, spare parts are described as being supplied for replacement of existing components of a device such that these components do not change the performance of a device.  An accessory may have an impact on the performance of a device or affect performance of a device.  There is a guidance document for accessories https://www.fda.gov/media/90647/download though while does define spare parts, it does define accessories.  Spare parts are the replacement part of existing components and not an accessory which gets added on.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Spare parts

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2023 09:13
    This message was posted by a user wishing to remain anonymous

    Spare parts are just spare parts, unless they meet the definition of device or accessory.


    Original Message


  • 4.  RE: Spare parts

    Posted 20-Jun-2023 13:59

    There is a sperate interpretation for these three terms as per FDA ,

    Spare parts refer to components or parts of a medical device that are meant to replace damaged or worn-out parts to maintain the device's proper functioning.

    Components are individual parts or elements that make up a medical device. These can include electronic circuits, sensors, cables, connectors, and other essential elements that contribute to the device's overall functionality.

    Accessories-These are additional components that are intended to be used with a medical device to aid in its performance or functionality. Accessories are classified separately from the main device.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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