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  • 1.  Device label and Precription only device statement

    Posted 05-Jun-2017 19:43

    Hi ,

     

    Needed advice on the device label and requirement of Rx only statement for the device label (for ophthalmic ultrasound & lasers). Our IFU does include the statement  'Caution: Federal law restricts this device to sale by or on the order of a qualified ophthalmic physician.' Does it need to be included on the device label as well?

     

    Thanks & Regards,

     

    Rashmi Pillay

    Regulatory Affairs Associate

    Ellex Medical Pty Ltd
    3, Second Avenue, Mawson Lakes

    Adelaide, SA 5095, Australia 
    T + 61 8 7074 8105
    F +61 8 8104 5231

    rpillay@ellex.com

     



  • 2.  RE: Device label and Precription only device statement

    Posted 05-Jun-2017 20:25

    Hello Rashmi,

     

    Either the "Rx Only" symbol or the full narrative form you've given must appear on the "label" pursuant to FDA's 21 CFR Part 801.109.  FDA defines "label" as the display of written, printed, or graphic matter upon the immediate container.  Therefore it is insufficient to have the prescription use statement only on the IFU.

     

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------

    Original Message


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