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Medical Device Software Application Contract Manufacturer – FDA Establishment Registration

  • 1.  Medical Device Software Application Contract Manufacturer – FDA Establishment Registration

    This message was posted by a user wishing to remain anonymous
    Posted 19-Dec-2022 08:26
    This message was posted by a user wishing to remain anonymous

    Dear Forum,

    A software development company is creating a software application for our medical device. It will be labeled with our company as the manufacturer, with our UDI, and we will be listing the product under our device establishment registration. Does this software company need to also register and list?

    Thank you for your response in advance!



  • 2.  RE: Medical Device Software Application Contract Manufacturer – FDA Establishment Registration

    Posted 26-Dec-2022 18:17
    Hello Anon,

    This is a great question and I think the answer to your question is No but would love to hear from others. 

    If you see the below Establishment Types, there is not a category that fits the role of your software development company. 



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    Ajit Basrur
    Worcester MA
    United States
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