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  • 1.  510(k) eCopy Cover Memo

    This message was posted by a user wishing to remain anonymous
    Posted 19-Dec-2019 12:58
    This message was posted by a user wishing to remain anonymous

    Is it still required to submit an original hard copy Cover Memo with a wet signature or digital signature in addition to the signed PDF version that is included in the 510(k)?


  • 2.  RE: 510(k) eCopy Cover Memo

    Posted 19-Dec-2019 20:02
    Yes. In fact, that requirement was just reiterated by FDA a few days ago in its updated eCopy guidance document.

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

    Original Message


  • 3.  RE: 510(k) eCopy Cover Memo

    Posted 20-Dec-2019 11:19

    Yes, I agree with Kevin.

     

    Also in my recent experiences I have sent FDA both formats either Wet Signature or Printed Image of Signature on the 510(k) Cover Letter along with the full validated eCopy on a USB flash drive and both were accepted. And yes also happy to see it officially this week as a final FDA rule to no longer require the full printed paper version. Many printers will be spared printing thousands of pages. ��

     

    Dallas L. Thomas, RAC, MHA, MPA, Certified Lead Auditor ISO 13485:2016

    Medical Device Regulatory, Quality, Compliance, and Auditing Consultant

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  • 4.  RE: 510(k) eCopy Cover Memo

    Posted 20-Dec-2019 12:02
    We include a hard copy cover letter (from a pdf with an electronic/not wet signature) within a binder that contains the submission CDs.  It has been accepted by the FDA with no issues.
    Kind regards

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    Jody Fleming RAC
    Associate Director, Regulatory Affairs
    San Diego CA
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    Original Message


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