Regulatory Open Forum

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  • 1.  Medical device labeling

    Posted 12-Oct-2022 11:34
    Hello all,

    A question related to device labeling: If an implantable device is intended for both the pediatric and adult populations, do we require to list the weight of the pediatric population on which the device can be used?

    Thanks!

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    Shikha Malik
    Sr. Regulatory Affairs Specialist
    Frisco TX
    United States
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  • 2.  RE: Medical device labeling

    Posted 13-Oct-2022 03:55
    Hello Shikha,

    When you say labelling, maybe you are referring to all information which would be included with the finished medical device.  It is hard to say without knowing the exact implant and indications for use, but on the actual device label, probably not.  Though within the instructions for use and maybe a surgical technique guide (if created) would have this type of information.  The specifics to the indications for use, clinical use of the medical device, and other warnings/cautions of the device would need to be known for providing a concise answer.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Medical device labeling

    Posted 13-Oct-2022 07:50
    Yes, Shikha, when weight is an important patient characteristic when using the device, the labeling should include this consideration regardless of patient age. The harder question is related to scientific substantiation for your labeled weight range. Be sure to label with substantiated data as your guide. Why is patient weight, specifically, a labeling issue for your device? How was use at different patient weights verified and validated?


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    Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
    President and CEO
    Frestedt Incorporated (www.frestedt.com)
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
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    Original Message


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