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  • 1.  Device Listing for an accessory/component manufacturing establishment

    Posted 22-Mar-2019 10:37

    Establishment 1 is manufacturing a 510 k cleared device and has the K number on its device listing.. 
    Establishment 2 is manufacturing an accessory/component for the device manufactured at Establishment 1
    As well as providing the accessories/components to Establishment 1, Establishment 2 also ships the ietms as spares to a warehouse for onward shipping direct to customers.

    I believe Establishment 2 has to register and list these components as they are for distribution to the end user but how do they list the components?
    Do they use the same listing as Establishment 1 ie K# with the description of the full device or use the same K# with a description of the component? 

    I would be grateful for any help with this
    regards
    Mike

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    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
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  • 2.  RE: Device Listing for an accessory/component manufacturing establishment

    This message was posted by a user wishing to remain anonymous
    Posted 06-May-2019 10:50
    This message was posted by a user wishing to remain anonymous

    Is Establishment ​2 the legal manufacturer of this thing, or are they a contract manufacturer for Establishment 1?
    Is this thing a medical device accessory, or is it a spare part?
    https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories
    Original Message


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