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Are most De novos failing?

  • 1.  Are most De novos failing?

    Posted 18-Feb-2020 19:54
    Continuing on with my De novo analysis, I found myself wondering how many De novo decisions had yet to be posted, and therefore were not included in my previous analyses.  After some number crunching, I was at "No, that can't be right." So I did some more number crunching, and then I was more like stunned.  Also puzzled.  It looks like over half of De novo submitted in 2015 and 2016 failed, in one sense or another.

    I'm attaching my analysis.  Interested to hear what others think.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------


  • 2.  RE: Are most De novos failing?

    Posted 19-Feb-2020 07:50

     

     

    Seems to me a pretty good analysis, Julie.  I especially like the approach you took to analyzing the data in the tables on page 2.  The data show just what you would expect: the mean (or median) time to grant de novos is greater than that for 510(k)s, and less than that for PMAs.

     

    I can't disagree with your conclusions either.  I suppose it's possible that FDA eventually decided that some de novos should have been 510(k)s, but that number would likely be pretty small (if not zero).

     

    Thanks for doing this, it's very informative.

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     




    Original Message


  • 3.  RE: Are most De novos failing?

    Posted 19-Feb-2020 08:40
    Edited by Julie Omohundro 19-Feb-2020 23:07

    Thanks, Ted.  Any thoughts on whether the success rate is likely to improve in the near term, and, if so, why?  I considered that 2015 and 2016 were pre-user fees, but I haven't been able to come up with a reason for user fees to have much impact on success rates, just review times.

    I would advise treading cautiously on the "informative."  I'm still trying to figure out how to do all this. 

    I think you will probably understand what I mean when I say that you can't really understand what data are telling you unless you know their life story.  It's hard to know where pitfalls might lie, in terms of making a wrong assumption.  Without transparency on the underlying processes, I'm having to feel my way...which, I must admit, is part of the fun. :)  Still, don't want to mislead anyone else into taking a wrong turn with me, in case they are in a hurry to get where they are going.

    For now, I will happily settle for "thought provoking."



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 4.  RE: Are most De novos failing?

    Posted 19-Feb-2020 09:07

     

     

    Hmmm, good question.  I guess I'm skeptical about success rates improving any time soon.  I'm also not seeing a reason user fees would help, unless the critics are correct that fees intrinsically bias FDA.  FWIW, I do not believe that user fees create any real bias--though they can lead to a *perceived* bias.

     

    I know exactly what you mean about what it takes to reach a deep understanding of data (so it can be used properly).  When I train new regulatory staff who will be using clinical data, I always ask them to go on a few site monitoring visits.  I consider it essential for them to understand the inherent limitations of clinical data, and just how much work it takes to get to solid interpretations of important outcome measures.

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     

     

     




    Original Message


  • 5.  RE: Are most De novos failing?

    Posted 19-Feb-2020 18:39
    Edited by Julie Omohundro 19-Feb-2020 23:08

    I think money always matters.  The questions are how and to whom and why. 

    The lack of user fees either definitely slowed the review of De novos.  Declining to accept over half of them for substantive review would be the quickest way to stop spending resources on applications that were not going to bring in any user fees.  And pushing them to 510(k) or PMA would convert them into paying customers.

    I could probably spin hypotheses all day long, but without transparency, I'd have no way to test them.  But maybe when we have a couple of years' worth of data on De novos supported by user fees, something will emerge.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 6.  RE: Are most De novos failing?

    Posted 19-Feb-2020 08:15
    Edited by Rob Packard 19-Feb-2020 08:16
    Hi Julie,

    I did the same analysis of 510(k), De Novo, PMAs for 2019. I don't know what the final number of De Novo submissions was in 2019, but typically it is around 60 submissions. In 2019, there were 21 De Novo applications approved. Therefore, we were well below 50%. What was even more startling is that the average approval time was 307 days. Therefore, the FDA target for days to approval of 150 days is not even close, and the goal of 120 days stated in the final rule is worse. From my own experience, it seems that a lack of proper clinical study design is the biggest obstacle.

    As an aside note, it appears that the 510(k) clearances are taking longer as well. The FDA is reporting performance based upon time that the review clock is running, but I appears that the submissions are being stopped more frequently and for longer periods of time. This also reinforces my own personal experiences with submissions.

    ------------------------------
    Rob Packard
    Shrewsbury VT
    United States
    ------------------------------

    Original Message


  • 7.  RE: Are most De novos failing?

    Posted 19-Feb-2020 08:53
    Edited by Julie Omohundro 19-Feb-2020 09:30
    Rob, don't get me started on "proper clinical trial design."  Really. That day will come, but it's not today.

    However, I can stay on point and comment that, whatever the biggest obstacle might be, when it comes to De novos failing, it's a proximate cause, and the root cause is buried deep.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: Are most De novos failing?

    Posted 23-Feb-2020 18:55
    Due to lack of transparency, we will never know the total number of 510(k), De novo, or PMA submissions in any year.  Base on DEN numbers that have been posted to the CDRH website so far, at least 40 De novos were submitted in 2019.  Of these, three have been posted as whatevered in 2019 and another two so far in 2020.

    Which final rule?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 9.  RE: Are most De novos failing?

    Posted 24-Feb-2020 09:46
    FDA does post some #s in their MDUFA quarterly reports.

    Link to latest one here:

    https://www.fda.gov/media/135471/download

    There is a section on de novo submissions.

    g-
    ​

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 10.  RE: Are most De novos failing?

    Posted 24-Feb-2020 10:13
    It does indeed "post some #s." :)

    I think it will be at least a year, probably more like two, before I'm ready to look at the numbers in the MDUFA reports.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 11.  RE: Are most De novos failing?

    Posted 24-Feb-2020 02:55

    Julie

    The straight de novo stats will never tell the full story.  Point is almost all de novos are preceded by one or more presubs in which the thorniest regulatory issues are ironed out by discussion and negotiation.  None of those activities are captured in the process time stats.

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------

    Original Message


  • 12.  RE: Are most De novos failing?

    Posted 24-Feb-2020 08:44
    Edited by Julie Omohundro 24-Feb-2020 10:35
    Arthur,

    Agreed.  At best, these stats suggest there is a full story to be told.

    I would have thought that almost all de novos were preceded by one or more presubs, but I'm not aware of any way to confirm even that much of the story.  As for ironing out the thorniest regulatory issues, to me these statistics suggest that, pre-sub or no pre-sub, the majority of De novos are being submitted with the thorniest regulatory issues still quite rumpled.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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