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  • 1.  Dual Submission Program

    Posted 07-Jul-2016 19:59

    Hello smart colleagues! 

    Can anyone share their experience with the Dual Submission Program for IVDs?  Is it "better" or "easier" to do than the separate processes of 510(k) and CLIA Waiver categorization?  Looking for some practical experience rather than "how to" feedback.

    Thanks in advance.

    Cheers,

    Melissa

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    Melissa Walker RAC
    President & CTO
    Graematter, Inc.
    St Louis MO
    United States
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  • 2.  RE: Dual Submission Program

    Posted 08-Jul-2016 17:58
    Melissa,

    "better" and "easier"?

    In view of getting cleared for 510(k) and waiver application under the CLIA of 1988, I would say so and it is faster overall.  That is because the dual submission is subject to MDUFA (e.g., 210 days of review time).

    But in reality, when a firm considers additional consulting fees for preparing a waiver app in addition to 510(k) submission, separate submissions are rather preferred.  

    Personally, I prefer a dual submission at the same time.  But I go with my client's preferred way!

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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