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2015 Annual FDA Medical Device Quality System Data

Discussion in 'Medical Devices (21 CFR Part 820)' started by Ronen E, Mar 17, 2016.

  1. Ronen E

    Ronen E Well-Known Member

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  2. MarkMeer

    MarkMeer Well-Known Member

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    Doesn't seem like much has changed...
    While this data is interesting, its value is questionable, as there is no indication of the severity of the observations.
    It'd be nice if the FDA had some sort of observation ranking system, so we'd have a clearer idea of whether these observations are due to relatively minor infractions versus total negligence...

    Question: what does "OAI", "VAI" and "NAI" (slide 8), mean?
     
  3. Ronen E

    Ronen E Well-Known Member

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    Off the top of my head:
    OAI - Obligatory Action Indicated
    VAI - Voluntary Action Indicated
    NAI - No Action Indicated

    Or something.
     

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