Regulatory Open Forum

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  • 1.  Any Class 3 devices OTC?

    Posted 17-Jan-2017 10:07
    Does anyone know of any examples of Class 3 PMA devices that are (or through later supplemental approval became) OTC devices?  I only know of prescription ones and assume that all are, but I was challenged with this question.  I have researched this but cannot find any examples of OTC.

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    Debbie Koeneman
    Consultant
    Mesa AZ
    United States
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  • 2.  RE: Any Class 3 devices OTC?

    Posted 17-Jan-2017 11:26

    The problem is that OTC/Rx is not a device attribute listed as part of the classification page. For 510(k) devices, one must read the clearance letter. I’ve seen the same device by Product Code with different OTC/RX classifications in different clearance letters.

     

    However, I believe that that a home use HIV test kit, Product Code MVZ, is an example of a Class III, PMA, OTC device.



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    Dan O'Leary
    Swanzey NH
    United States
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