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  • 1.  ecopy FDA eSubmitter software

    This message was posted by a user wishing to remain anonymous
    Posted 03-Feb-2020 10:09
    This message was posted by a user wishing to remain anonymous

    Hi all,
    I am not sure I fully understand the purpose of the eSubmitter Software.
    - Is it used only to rename your own pdf files using FDA's convention (001_XXX, 002_XXX) or it has any other purpose?
    - Does it perform any check of the format of the pdf (e.g., fonts, hyperlinks, bookmarks)?
    - Should we upload in the flash drive the alphanumeric folder or only its content?
    - Should we provide also a scanned version of the coverletter? Should this be uploaded in the e-Submitter as document 001_?
    - Do you usually send only one flash drive to the FDA (or two, just in case one of the two does not work)?
    Thanks a lot for your help!


  • 2.  RE: ecopy FDA eSubmitter software

    Posted 04-Feb-2020 04:22
    Hello,

    The eSubmitter software is checking the file naming, file structure, and folder structure to make sure it can be taken into the FDA's electronic system.  It does not check the format of the PDF, so just read through the eCopy Specification guidance by FDA, it is pretty clear on the file and folder structure and use of the eSubmitter software.

    I personally only provide a hard copy cover letter with the USB stick and then just have each of the 20 sections on the USB stick starting with a Table of Contents.  People do it differently as some have file 001 as a cover letter, file 001 as the completed RTA checklist, file 001 as table of contents.  You only need to send one flash drive to the FDA.  I have only sent one for quite many submissions now in the last year and never had any problem.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: ecopy FDA eSubmitter software

    This message was posted by a user wishing to remain anonymous
    Posted 04-Feb-2020 09:09
    This message was posted by a user wishing to remain anonymous

    Thanks a lot!
    Just to make sure my understanding is correct: do you take only the content of the the alphanumeric folder that the e-submitter creates?
    Original Message


  • 4.  RE: ecopy FDA eSubmitter software

    This message was posted by a user wishing to remain anonymous
    Posted 04-Feb-2020 09:09
    This message was posted by a user wishing to remain anonymous

    - Is it used only to rename your own pdf files using FDA's convention (001_XXX, 002_XXX) or it has any other purpose?

    Pretty much, as well as directory structure if you chose the Volume based approach, and ensuring MISC folder is in ZIP format

    - Does it perform any check of the format of the pdf (e.g., fonts, hyperlinks, bookmarks)?

    I don't believe so. There is a separate Validator tool, but I don't think it does too much of that. This is nowhere close to as powerful as the drug submissions gateway tool, even though the screen user interface looks the same.

    - Should we upload in the flash drive the alphanumeric folder or only its content?

    Very good question - ONLY the content, not the alphanumeric folder (which makes one wonder why it is created)

    - Should we provide also a scanned version of the cover letter? 

    Yes.

    Should this be uploaded in the e-Submitter as document 001_?

    It should be in there. Doesn't necessarily need to be 001_. In fact, your first document is typically the CDRH form.

    - Do you usually send only one flash drive to the FDA (or two, just in case one of the two does not work)?

    Just one. Two may confuse them. If you have any doubts one will not work, test and retest at home. Once it passes the eCopy check, FDA will acknowledge via E-mail.

    BTW, medical device consultant Rob Packard did a great webinar on the eCopy process a few years back. He covered some of these topics. I followed it and the FDA guidances and had no problems with the first 510(k) I submitted (I submitted via CD, not USB though).
    Original Message


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