Regulatory Open Forum

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  • 1.  510(k)

    Posted 25-May-2023 07:05

    I have a question regarding EMC.
    I want to submit a new tradtional 510(k) and we had the EMC report and documents back in 2019.
    My question is should we do a new test regarding this new submiision? or we could just use the old report.
    Thanks.



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    Silu Zhang
    West Vancouver BC
    Canada
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  • 2.  RE: 510(k)

    Posted 25-May-2023 07:39

    If your testing was done to IEC 60601-1-2 4th Edition, and you have not changed the electrical profile, you should be good. Good luck.



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    Philip Reece
    Director of Quality and Regulatory
    Auburn IN
    United States
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  • 3.  RE: 510(k)

    Posted 25-May-2023 07:45
    Great! Thank you so much!!

    --
    Kind regards, Lulu





  • 4.  RE: 510(k)

    This message was posted by a user wishing to remain anonymous
    Posted 26-May-2023 08:21
    This message was posted by a user wishing to remain anonymous

    Dear Zhang,
    be aware that the FDA has a new Guidance on EMC Requirements. Please check internal if 5G and frequences are part of the Reports.
    Kind regards
    Anonymous




  • 5.  RE: 510(k)

    Posted 26-May-2023 09:08

    ok Great,
    Thanks for the info!



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    Silu Zhang
    West Vancouver BC
    Canada
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  • 6.  RE: 510(k)

    Posted 26-May-2023 10:05

    Hello Silu,

    Yes, should be ok as others indicated make sure it conforms to current FDA requirements.  The electrical disturbance standard is an international standard and some countries have specific requirements, so make sure the United States requirements are being met with the testing report you have available.  If you are unsure, you should be able to ask the testing laboratory for any deviations by country.



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