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Non-Clinical Performance Bench Testing FDA 2019 Guidance

  • 1.  Non-Clinical Performance Bench Testing FDA 2019 Guidance

    Posted 12-May-2021 16:14
    Hi all,
    The excerpt below from the 2019 FDA Guidance on Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions related to test sample size/selection is causing a bit of discomfort within my organization:

    Finally, your test sample selection should account for both inter- and intra-lot variability by examining multiple manufacturing lots, when appropriate (e.g., when it is expected that such sampling is likely to impact the testing results and/or is needed to adequately capture the variability in the testing results).

    Accepting that this is guidance, not regulation, but represents the agency's current thinking, I'd be very interested to hear how others have approached this, as multiple manufacturing lots has not been typically been a part of design verification.   Has the FDA identified the lack of inter/intra lot variability during a 510(k) review as an issue for different devices?   

    We've been discussing several different options to appropriately test inter and intra lot variability. 
    Is it as simple as having 3 different operators complete a manual assembly process?
    Should we access a known wear item at its end points over multiple lots?
    Or adjust critical process parameters over multiple lots?

    Would be very interested to generally hear how other organizations are meeting this (relatively) new expectation.


    Ruthann Rapp
    Clinton MA
    United States