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  • 1.  Pre-Sub Meeting Supplement FDA Feedback response timing

    This message was posted by a user wishing to remain anonymous
    Posted 29-Aug-2017 14:02
    This message was posted by a user wishing to remain anonymous

    ​​

    Hi Everyone,

     I was wondering what experience fellow RA's have had regarding the Pre-Sub Meeting Submission process for a PMA (or even a 510k). There is an option to submit follow-up discussions on the Pre-SUB Meeting as a Supplement; however, the guidance document does not state the length of time for a Pre-Sub Supplement to be scheduled or review by FDA.  I was wondering if it was 30 days since IDE Supplements are typically reviewed in 30 days; I did not want to assume the same for Pre-Sub Supplements or does FDA response time vary based on the content of the Supplement? 

    Would someone please be able to discuss their experience the length of time a follow-up question response/teleconference would be scheduled for a Pre-Sub Supplement. Has the experience been based on the complexity of the followup question, (e.g review data (longer) or review testing protocol (30days)?

    Looking forward for your feedback so I may plan timelines with my team.

    Thank you in advance.



     


  • 2.  RE: Pre-Sub Meeting Supplement FDA Feedback response timing

    Posted 30-Aug-2017 07:53
    ​Hi there,

    I have submitted a number of Pre-Subs for 510(k)s previously and whenever we needed a supplement we did that as well. The process runs just as long as the initial Pre-Sub. So if you are short on time I recommend you to try and resolve the issue outside the Pre-Sub process. This however only works for simpler questions and also your FDA reviewer needs to buy in.

    If you would like to discuss more, you may see me after my RAPS convergence presentation on the topic on September 11 at National Harbor, MD, if you are happen to be there.

    Good luck

    Andreas


    ------------------------------
    Andreas Wiegand RAC
    Director US Affairs
    Siemens Healthcare Gmbh
    Marburg
    Germany
    ------------------------------

    Original Message


  • 3.  RE: Pre-Sub Meeting Supplement FDA Feedback response timing

    Posted 30-Aug-2017 09:40
    FDA has 90 days to review a medical device pre-sub (although there are different types of pre-subs - see the link below for the guidance document).  Typically, however, the lead reviewer will contact you within a few days after FDA receiving the submission to schedule a meeting date (if appropriate) or to introduce themselves.   There is no limit to the number of follow-up pre-submissions that a firm can submit to FDA to get further clarification on the required studies (but after a while FDA may gently encourage you to send them an actual submission).

    https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf


    ------------------------------
    Joshua Levin, Ph.D., RAC (US)
    Personal Genome Diagnostics, Inc.
    Baltimore MD
    United States
    ------------------------------

    Original Message


  • 4.  RE: Pre-Sub Meeting Supplement FDA Feedback response timing

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2017 16:28
    This message was posted by a user wishing to remain anonymous

    ​Dear A,

    I recently submitted a Pre-Submission for 510(k) supplement and I too found that the timeframe for a response to a supplement is not all that clear in the guidance.  I heard back our lead reviewer 13 calendar days after I submitted the supplement and was informed that the review had begun and I would be getting the review via e-mailed as agreed.  It has been 35 calendar days so far: I'm assuming the time frame will be the same as for the Pre-Submission, 75 to 90 days.

    A too.

    Original Message


  • 5.  RE: Pre-Sub Meeting Supplement FDA Feedback response timing

    Posted 30-Aug-2017 17:38
    Qsubs and ​Supplements all go through eCopy acceptance (5 days) and an Acceptance Review (14 days), prior to the meeting/telecom being scheduled, so you need to add that into your timeline.  There's a great slide deck from FDA that contains the process steps below - https://www.fda.gov/downloads/training/cdrhlearn/ucm387291.pdf

    　　 

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
    ------------------------------

    Original Message


  • 6.  RE: Pre-Sub Meeting Supplement FDA Feedback response timing

    Posted 30-Aug-2017 18:49
    Hi A,

    Andreas' response is correct. Trying to get interactive review from the lead reviewer is the most efficient method, but only works if the reviewer buys in and the questions are relatively simple.

    If you are questioning feedback from the original Q-sub, a "Submission Issue" meeting request might be the best method. The guidance states that reviewers are supposed to schedule a meeting within 21 days of the submission getting stamped into the FDA. I've seen inconsistent responses from FDA to these requests; however, I would say it's worth a shot if you feel that it meets the qualifications.

    Page 23 on the linked guidance - https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf

    Best,

    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
    ------------------------------

    Original Message


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