Regulatory Open Forum

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  • 1.  Electronic Submissions to FDA

    Posted 27-Aug-2019 04:40
    Hi All.

    We are looking to do our first submission to the FDA towards the end of the year / early Q1 2020 and I was wondering whether the FDAs electronic submission program could be used or whether they are still rolling this out as I have heard conflicting information. We will be submitting a Medical Device under 510(k).

    Thanks.

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    James
    Head of QARA
    UK
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  • 2.  RE: Electronic Submissions to FDA

    Posted 29-Aug-2019 14:56
    If you're planning a 510(k) submission, there's a discussion about this in the forum under the heading, " 510(k) paper copy".

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    Stephanie Mays
    Senior Regulatory Affairs Specialist
    Redmond OR
    United States
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    Original Message


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