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  • 1.  Submitting an eCopy

    This message was posted by a user wishing to remain anonymous
    Posted 16-Dec-2019 10:10
    This message was posted by a user wishing to remain anonymous

    Hello. 

    I am submitting meeting minutes to the FDA following our first ever pre-submission and I was wondering whether I have to include a paper copy  with the eCopy? 

    The eCopy will contain a Cover Letter, Meeting Minutes and the slides that were presented. I was planning to print out just the cover letter and would send this with the flash drive, once it has passed the FDA Validation tool! Is this correct? Do I need to print out all the minutes or is just the cover letter ok?

    Thanks.


  • 2.  RE: Submitting an eCopy

    Posted 17-Dec-2019 03:24
    Hello Anon,

    Not anymore from the finalisation of the electronic only available rule (recently posted on RAPS news feed).  We have actually only been submitting eCopy versions of pre-submission (Q-Submissions, Q-Sub) for almost a year now including the original request, additional information, and the meeting minutes.  In fact, talk with your reviewer or main contact because sometimes you may be able to submit meeting minutes only through email.  For meeting minutes, I submitted the draft to the reviewer through email, they commented, and then I submitted the official in the eCopy sending in a USB stick.  For the eCopy make sure it passes the validation and I always attach a 1 page cover letter just explaining what the USB stick is for.  I label the USB stick with the 510(k) number or Q-Sub number (if known).

    I hope FDA is recycling all these USB sticks they will be getting haha !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Submitting an eCopy

    Posted 17-Dec-2019 04:53
    Hi Anon. 

    I submitted FDA minutes back in the summer and followed the same approach that you have noted. This was accepted by the FDA. As Richard noted, definitely use the FDAs eSubmitter to confirm the document format before sending your USB stick.

    James

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    James
    Head of QARA
    UK
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    Original Message


  • 4.  RE: Submitting an eCopy

    Posted 17-Dec-2019 08:03
    ​Your plan will work. You need only to send a printed cover letter with the electronic version, and you only need to send one electronic version.  I have used this successfully with several types of submissions.

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    Sarah Parsons RAC
    Director Regulatory Affairs, Diagnostics
    Pittsford NY
    United States
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    Original Message


  • 5.  RE: Submitting an eCopy

    Posted 17-Dec-2019 11:57
    you are correct. you just need to submit a printed copy of the cover letter along with the ecopy on a flash drive.

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    Elisabeth Neely RAC
    Sr Vice President, Clinical and Regulatory Affairs
    Houston TX
    United States
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    Original Message


  • 6.  RE: Submitting an eCopy

    Posted 17-Dec-2019 16:56
    If you follow the current final eCopy Program for Medical Device Submissions Guidance issued in December 2019, it provides the current preferred process as you had described and mentioned by others from earlier today.

    As stated in the Guidance, "It is recommended that your company cover letter also be included as a PDF in your eCopy, but it is not required."  As practice, I include a pdf copy of the Cover Letter in the eCopy just to be comprehensive. 


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    Ya-Chen Tonar
    Clinical and Regulatory Affairs Consultant
    Carmichael CA
    United States
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    Original Message


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