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510(k) for IVD which includes lab processes

  • 1.  510(k) for IVD which includes lab processes

    This message was posted by a user wishing to remain anonymous
    Posted 15-May-2018 08:48
    This message was posted by a user wishing to remain anonymous

    Hi Colleagues，

    I am developing a regulatory plan for our IVD product. The whole IVD test system includes a few components(instruments) and lab processes. In 510(K) or De Novo submission, what are the requirements for those lab processes?  The lab processes are oversight under CLIA regulations.  What data FDA wants to see?

    Thanks in advance.


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