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  • 1.  Is FDA accepting Pre-Subs

    Posted 20-Jul-2020 14:44
    Hello all,

    This question is with regards FDA accepting Pre-Subs for any proposed new device in the current scenarios.
    I heard that FDA is not accepting any Pre-Subs?

    Is this true or the process is a little slow?

    Appreciate any feedback from the group.

    Thank you
    Kind Regards,
    Aliva Das

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    Aliva Das
    Frisco TX
    United States
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  • 2.  RE: Is FDA accepting Pre-Subs

    Posted 21-Jul-2020 03:21
    Hi Aliva,

    I haven't had any issues with Pre-sub requests recently.  You should be fine.

    Thanks,
    Colleen

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    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
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    Original Message


  • 3.  RE: Is FDA accepting Pre-Subs

    Posted 21-Jul-2020 04:01
    Hi Aliva,

    The US FDA converted all the face-to-face meeting to teleconference and as far as I know still only having teleconference or written response Q-Submission requests for the moment.  I have not heard when they might be resuming face-to-face meetings.  We had a couple in the last few months and was slightly slower to schedule, but these were initially teleconference so we had no issues.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Is FDA accepting Pre-Subs

    Posted 21-Jul-2020 08:45
    HI Aliva;

    I can confirm that FDA is accepting Q-Subs and "yes" the process has been very slow.

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    Shelley Looby
    Director, Regulatory Affairs & Quality Assurance
    Kansas City MO
    United States
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    Original Message


  • 5.  RE: Is FDA accepting Pre-Subs

    Posted 21-Jul-2020 09:30
    FDA is still accepting pre-subs, according to them. However, because of their workload, they are at times not hitting the timelines for pre-subs. Also, there are no in person meetings regarding pre-sub or anything else. Everything by telecon or video conference.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 6.  RE: Is FDA accepting Pre-Subs

    Posted 21-Jul-2020 13:44

    I submitted a Pre-Sub Request for a formal written response in May and the reviewing division (Neurostimulation-Neurology Devices, Division of Health Technology 5 B) has been very responsive and have met all time requirements for review, e.g., 15day Acceptance Review, receipt of 70 day Pre-Sub Written Feedback. I cannot speak with regard to the timeliness of other reviewing divisions, but I expect that they are also meeting their MDUFA IV commitments.


    Regards,

    Bob Wilkinson

    Resolute Regulatory Consulting



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    Robert Wilkinson
    President
    Port Barrington IL
    United States
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    Original Message


  • 7.  RE: Is FDA accepting Pre-Subs

    Posted 24-Jul-2020 10:17
    Hi,
    I agree with the responses provided re. pre-subs (or Q-subs as they are now called).  One note for you though, is if your product is for a coronavirus diagnostic for the office of in vitro diagnostics, who are currently very focused on cornonavirus emergency use authorizations (EUAs), then it is very likely that you could experience some prolonged delays.  FDA are prioritizing certain EUAs, and then pre-EUAs especially those containing data,  and routine pre-subs for coronavirus are not the current priority.  This is based on feedback FDA has provided at their townhall meetings re. diagnostics for COVID-19. 
    Kind Regards,
    Lubna

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    Lubna Syed RAC
    Global Director, Regulatory Affairs
    OakvilleONCanada
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    Original Message


  • 8.  RE: Is FDA accepting Pre-Subs

    Posted 27-Jul-2020 10:55
    Have done several pre subs in the last 5 months. All remote via conference all though.

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    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
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    Original Message


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