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  • 1.  Positive Control requirments

    Posted 17-Jan-2017 15:38
    Hello All,

    Are manufacturers required, by FDA, to provide a positive control with their IVD?

    Thanks for the insight!

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    Joy Pelfrey Director of RA/QA Norman OK United States
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  • 2.  RE: Positive Control requirments

    Posted 18-Jan-2017 08:15
    Hi Joy.
    Not sure if FDA "requires" this to be included or if it is something that a company can negotiate with the agency but as a user of any testing system I want a positive control.  Also, if there is some reason why there might be some question as to positive or negative result I might also look for a negative control depending on the test and whether or not something like water or some other standard stand alone lab material might be sufficient.  Reason is simple - the last thing I want is to call a sample negative when it is actually positive and have that information used to incorrectly treat a patient.  So in my mind it is always a positive to have a positive control (or at least a reference to a positive control) for any IVD. I came from a microbiology background so many times the positive control was simply a known culture collection species which is usually fine. But in other cases you might need to include something.  Obviously these are just my thoughts and I will be interested to hear what others think!

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    Victor Mencarelli Director - Regulatory Affairs Hain Celestial Group United States
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    Original Message


  • 3.  RE: Positive Control requirments

    Posted 18-Jan-2017 10:45
    As with many regulatory questions, it depends.  The use of controls is directed under the Laboratory guidelines (42CFR493). My experience is that for Class III products FDA expects manufacturers to provide controls so that the control material is produced under the same quality system as the test for which it is used. This is not necessarily the case for Class II IVD.  The control strategy that a manufacture has planned would be a good topic to address in a presubmission meeting with FDA

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    Sarah Parsons RAC Director Regulatory Affairs Janssen R&D Pittsford NY United States
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    Original Message


  • 4.  RE: Positive Control requirments

    Posted 18-Jan-2017 13:20
    Hi Joy,
    In addition to the previous responses, the FDA also recognizes many consensus standards for IVD evaluation. If the recognized standard for a performance test requires a positive control, I would consider this a "strong recommendation" from the FDA that a positive control be used.

    Best,

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


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