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  • 1.  IVD repro study

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2023 11:19
    This message was posted by a user wishing to remain anonymous

    Is it a PMA submission risk for 2 labs to use different DNA extraction methods for the reproducibility study?



  • 2.  RE: IVD repro study

    Posted 26-Jan-2023 04:01
    Hello Anon,

    There is probably not enough information to provide a succinct answer considering what is the device or how the results of the study are being used.  However, stating this is a PMA submission, assuming US FDA, you could reach out to the reviewer if you have an IDE or go through a Q-Submission meeting to hopefully answer the question whether it would be accepted in the submission or not.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: IVD repro study

    Posted 26-Jan-2023 07:21
    Hi, the short answer could be yes.  Take a good look at CLSI EP5 to see if you have built in the requirements of lab to lab reproducibility. Are you able to justify, based on your products sample to result strategy, that DNA isolation method is non-consequential? Is data available to prove it? It just adds to the burden of proof on your part and if your repro data is not impacted then the risk goes down. A great question for a presub.

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    Sarah Parsons RAC
    Principle, Northcoast Consulting
    Regulatory Affairs, Diagnostics
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