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  • 1.  IVD Clinical Study - "geographically diverse locations"

    Posted 03-Sep-2015 12:31

    FDA requires specimen collection from three "geographically diverse locations" for clinical studies for IVD medical devices.   FDA also requests that the collection yield at least 50 positive samples to be measured at each test site. Channeling specimen collection from geographically diverse collection sites can be quite a challenge to accomplish the positive specimen requirement. For some analytes, balancing the two, geographic diversity with a decent prevalence can be quite hard where the prevalence is more regional.  Does anyone have a definition of that term ("geographically diverse locations") or any practical experience (yours or someone you know :-) ) where enough geographical diversity was NOT included that you could share?   Would appreciate any insight.
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    Debra Hutson
    QA/RA ELITechGroup Inc
    ELITechGroup
    Bothell WA
    United States
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  • 2.  RE: IVD Clinical Study - "geographically diverse locations"

    Posted 04-Sep-2015 12:41

    Hello Debra,

    In our limited experience (3 510ks in the last 4 years) in the process for IVD clearance, FDA's main concern was 3 different locations.  They never pressed for them to be 3 "geographically" diverse locations.  We submitted using "reference laboratory" testing, "clinical laboratory" testing and internal testing.  We too work with disease of relatively low prevalence and were able to gain clearance on one particular IVD with a total of 50 positives, instead of 50 positives at each site.  We had to have multiple discussions to explain why it was not possible to get more and they eventually accepted our total numbers.

    Best of luck!

    ------------------------------
    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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  • 3.  RE: IVD Clinical Study - "geographically diverse locations"

    Posted 04-Sep-2015 16:24
    Debra,

    You state "FDA requires specimen collection from three "geographically diverse locations" for clinical studies for IVD medical devices."

    It is not a requirement but it is recommended.  With your justifiable reasons, you can negotiate with the FDA through Pre-Submission.

    For IVDs for influenza viruses, it is more strongly recommended. You may refer to 

    In fact, if you can collect samples from three sites, which are geographically diverse, your IVD's performance can be better demonstrated in your labeling depending upon your type of IVDs.

    Please note: one of director level personnel at OIR/CDRH/FDA was a recent college graduate (BS) in engineering with no experience in IVD 510(k)s.

    Why am I saying:  it warrants your need to definitely communicate with the review office through a pre-submission.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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