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  • 1.  FDA Q-Sub meetings - tips are apriciated

    This message was posted by a user wishing to remain anonymous
    Posted 10-Feb-2022 15:43
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,
    We have a Q-Sub meeting with FDA and I wonder if you have any tips to share so we can get the most out of the meeting.


  • 2.  RE: FDA Q-Sub meetings - tips are apriciated

    Posted 10-Feb-2022 15:59
    Have you reviewed the Q-Sub Guidance by the US FDA ?

    It's available here  https://tinyurl.com/2rmptv23/


    What kind of device is this ? What the main feedbck you seek from the FDA? Have you prepared a comprehensive list or points you wish to rise to the FDA during the meeting?

    ------------------------------
    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/2wkxp69y
    on US FDA eSTAR for 510(K)
    ------------------------------

    Original Message


  • 3.  RE: FDA Q-Sub meetings - tips are apriciated

    Posted 11-Feb-2022 03:51
    Hello Anon,

    Your question is a bit too broad to answer in a forum post, you might want to get assistance from a subject matter expert.  A couple points to be aware:

    • Ensure the Q-Sub is being used in the right context, e.g. classification versus feedback
    • Provide sufficient detail for the product so it is clearly understood
    • If there is unknown information, explain to reader expected or planned activities
    • Do not ask open-ended questions, make sure the questions are concise so they can be answered


    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: FDA Q-Sub meetings - tips are apriciated

    This message was posted by a user wishing to remain anonymous
    Posted 11-Feb-2022 11:14
    This message was posted by a user wishing to remain anonymous

    Hi,
    If you already have the Q-Sub meeting, congrats!  That means you already sent in your written request and list of questions.   It's not easy to even get a meeting these days.  Be prepared for FDA to cancel it at the last minute and tell you they will respond in writing.  If that happens, you can probably protest and get them to do the meeting.  
    If you have a meeting already, you have probably read the guidance. You will need to send your list of attendees and some slides that you want to present just before the meeting.  You should have experts present for each topic you intend to discuss.   Just remember to take good notes and send them to FDA within the deadline.  I think it's 15 days.  They will make changes if they disagree and then you will have to send a revised final copy.  
    -Also anonymous
    Original Message


  • 5.  RE: FDA Q-Sub meetings - tips are apriciated

    This message was posted by a user wishing to remain anonymous
    Posted 12-Feb-2022 12:27
    This message was posted by a user wishing to remain anonymous

    Hello Anon,
    Having just had my first ever Q-Sub call with FDA, here are my thoughts:
    if you know who's attending from FDA, look them up. Get their job title and proper form of address (Dr for PhD's or rank for those in Public Health Service). Be warm and respectful. 


    Admit what you don't know or understand. Ask clarifying questions until you know what they mean or want. That's what the meeting's for! Keep in mind they want you to succeed. 


    Above all be prepared-
    Know your  material.  I wrote a three page script and memorized it so I didn't fumble with notes during the video call.  Pick one presenter who does all the talking. Keep everyone else on mute so they can have sidebar conversations that help the presenter answer questions. 


    Assign a note taker so the presenter doesn't   have to talk and write at the same time. As soon as the call is ended review the notes with the team. Your memory will never be as fresh later. 

    Make sure you understand what the next steps are. I asked if we could use email interactively after the first call and the reviewer agreed. Now we email back and forth a couple times a week. 

    Hope this helps!


    Original Message


  • 6.  RE: FDA Q-Sub meetings - tips are apriciated

    Posted 14-Feb-2022 09:48
    I agree with what others have stated here. Having participated in a number of Q-Sub meetings you really won't know what points to discuss until you receive the FDA's written feedback which can come the day before or even the morning of your scheduled meeting. Be prepared to setup a quick internal meeting to figure out what the FDA is thinking, where there concerns are, and use the teleconference to clarify any misconceptions. This will be beneficial since you can set the record straight using the meeting minutes. Additionally, you should seek clarification on any of the written feedback from the FDA which you do not understand. If you fail to do this you have lost a valuable oppertunity. Don't forget the meeting is limited to 1 hour; as such, you need to know who, from your side, is going to speak about which item and don't stray too far from your designated talking points or you will run out of time. If you need any additional advice, feel free to reach out directly.

    ------------------------------
    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Website: www.biotexmedical.com
    ------------------------------

    Original Message


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