Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

De Novo Summary ODE 2015-2018

  • 1.  De Novo Summary ODE 2015-2018

    Posted 21-Oct-2019 15:08
    Attached are summary statistics for the 88 "direct" De novo decisions issued by ODE, 2015 through 2018.

    Average review time across all four years was 386 days, with a range of 28 to 870 days.

    ------------------------------
    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: De Novo Summary ODE 2015-2018

    Posted 22-Oct-2019 03:24
    Very interesting, especially as the vast majority were around Cardiology. Thanks for posting Julie. 


    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


  • 3.  RE: De Novo Summary ODE 2015-2018

    Posted 22-Oct-2019 13:23
    Happy to share.  I'm driven to do this kind of thing regardless (attributable to my OC/Asperger's tendencies, which I do not consider disorders, but more like super powers).

    As for cardiology, interesting, yes.  Exactly why, I'm still working on that.

    ------------------------------
    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: De Novo Summary ODE 2015-2018

    Posted 23-Oct-2019 02:51
    Cant say that I share the same super powers as yourself, am not a numbers person. Very interesting to see how things are looking and does highlight the lack of novel devices coming through in the industry. Maybe companies try their hardest to match a predicate because it is the easier route!

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


  • 5.  RE: De Novo Summary ODE 2015-2018

    Posted 23-Oct-2019 10:20
    Mostly because it's the (claimed) route that makes it easy to part fools and money.  From the perspective of actually getting a medical device on the market, the easiest route is the one that will get it there.  Much of the high failure rate attributed to medical device startups can undoubtedly be found in a disconnect between the two.

    If I live long enough, I may someday write a paper entitled "How the 510(k) destroyed innovation in medical devices."  If I thought I'd live longer, I might wait around to see if "...the medical device industry" might serve equally well as the title, but it's going to take some time for that one to play out.

    ------------------------------
    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: De Novo Summary ODE 2015-2018

    Posted 22-Oct-2019 10:11
    Edited by Julie Omohundro 24-Oct-2019 01:10
    Just a quick and belated caveat.  These statistics provide a decent overview of ODE's first 88 direct De novos.  Or, at least, right now I've counted 88.  Since posting this, I've already revised the mean number of days for review...twice.  Just by a few days, but still.

    Compiling this information is time-consuming, mind-numbing, and prone to error.  Moreover, there are a lot of quirks I haven't decided how to address yet.  Just one example...there are multiple dates to choose from, and, for example the receipt and decision dates posted on FDA's website and in the classification order often don't match.  Usually, they are just off by a few days, but sometimes by months.

    Far more important, these data represent a huge range of technologies and a dozen different intended uses (and indications).  That means these data mean very little. As far as average review times go, the main...perhaps only...thing they tell you is that CDRH has MDUFA commitments.  The main value these data have, IMO, is that they give you an easy answer to one of the first two questions everyone asks RA about any premarket submission. (Tuesday Trivia, lol.)

    If you want to get into the weeds in a particular area (e.g., cardiology), then these data give you a quick-and-dirty high-level first look, but if you are at all serious about it, you should pull the reclassification orders and summaries from the FDA's website and take a much closer look.  (Can't promise those will be "clean" either, as I'm quite sure there are some typos, and perhaps some more substantive errors, in FDA's information too.)

    This is a milestone for me, in that I finally got all the documents downloaded and data extracted through the end of the last year, before the current one ended.  But this is just a start.  It will be a very long time before there is enough data on De novos to take these numbers seriously.  Which means I should probably start taking better care of myself  :)

    ------------------------------
    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


  • 7.  RE: De Novo Summary ODE 2015-2018

    This message was posted by a user wishing to remain anonymous
    Posted 07-Nov-2019 13:43
    This message was posted by a user wishing to remain anonymous

    With the de novo fee changing from $0 to $100,000+ in FY2018 (I think), the number of de novos will likely drop like a rock! Even the $25,000+ for a Small Business (where true innovation is likely to originate) can be a huge barrier.
    Original Message


  • 8.  RE: De Novo Summary ODE 2015-2018

    Posted 07-Nov-2019 20:52
    The MDUFA fees are negotiated with the industry's power players.  Whether this means they are ready to pay the negotiated De novo fee, or they don't care what it is because they don't expect to use it, time may tell.  Or maybe not.  In the latter case, they may have even "negotiated" a higher De novo fee in return for keeping the 510(k) fee in check.  Time will tell, and I for one will be very interested to see.

    In theory, whether or not a user fee is a barrier, and how much of a barrier it is, is determined entirely by the value represented in bringing a device to market.  Low user fees, low-value device.  High user fees, high-value device.

    In practice, an unknown number of devices that potentially offer high value to the market don't make it because they fall into inept hands, and, at least in the past, a low-value device would make it based on market valuation voodoo.  Also in theory, the industry continues to consolidate, the larger companies should have less and less interest in market valuation and more and more interest in actual market value.  Time will tell how/if this works out in practice.  There is speculation that, after decades of chasing market valuation, these companies may not have developed the knowledge needed to ascertain actual market value.

    Do you have any data to support your claim that "true innovation" is more likely to originate from small businesses?

    ------------------------------
    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: De Novo Summary ODE 2015-2018

    Posted 08-Nov-2019 17:30
    Minor point - user fees are negotiated with the several trade associations, which may include "power players" but also include any company that wants to be a member and participate.

    Additional point - the user fee in the most recent MDUFA was implemented in return for FDA agreeing to review time goals for de novo submissions; without one, would not have the other.

    g-

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

    Original Message


  • 10.  RE: De Novo Summary ODE 2015-2018

    Posted 08-Nov-2019 19:30
    Edited by Julie Omohundro 08-Nov-2019 19:31
    Ginger, thanks for the additional info. 

    By "power players," I guess (didn't really give it detailed thought) I was referring mostly to the trade associations themselves, since the purpose of any organization is to consolidate power.  I'm sure some of the member companies would also be considered power players in their own right, and others would not.

    I think the MDUFA user fees have always been implemented in return for FDA agreeing to review time goals, not just in the most recent MDUFA?

    To clarify, the negotiations include any company that wants to be a member and participate, and that is willing to pay the membership fee, correct?

    ------------------------------
    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: De Novo Summary ODE 2015-2018

    Posted 11-Nov-2019 10:00
    Julie,

    Answering a couple of your questions.

    - yes, MDUFA has always been linked to review time goals, among other things (see the historical "committment letters"). But until MDUFA4, there was no commitment on De Novo's while there was for 510(k), PMA etc. It was felt by some that this meant that FDA only worked on De Novo submissions when there was "nothing else to do" and thus led to long review times. Thus a fee and related review timing was agreed upon in that round.

    - yes, to join a trade association there is generally a membership fee. The MDUFA4 negotiations include 4 different trade associations (AdvaMed, MDMA, MITA and the last I forget offhand). These have various membership fees and often a sliding scale based on company size. They also, I will note, generally work by consensus, so very little gets through that isn't either agreed upon by all engaged members or simply laid down by FDA as a "must have" they can't be negotiated down from

    g-

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

    Original Message


  • 12.  RE: De Novo Summary ODE 2015-2018

    Posted 11-Nov-2019 18:54
    FDA only worked on De Novo submissions when there was "nothing else to do"

    Probably a bit of an overstatement, given that eventually De novos got reviewed, and I doubt it was because CDRH literally had "nothing else to do."  Otherwise, I can't imagine how anyone could possibly have expected otherwise.  Oh...them. Yes, if you cast a wide enough net for "anyone," then, sigh, I regret that I don't even have to imagine. The way I saw it, CDRH wasn't going to negotiate a fee until it had worked through the process enough times to have some idea of what kind of timeframes it could agree to.

    They also, I will note, generally work by consensus, so very little gets through that isn't either agreed upon by all engaged members

    This leaves wide open the question of how many companies actually agreed to the user fees and timeframes.  It's a truism that the overwhelming majority of the members of any organization are not engaged with it or its activities.

    I would kill to know which companies actually thought a fee of $100,000 (or even $25,000) was a reasonable fee to pay CDRH to merely classify a device as I, II, or III.  If any companies actually thought this. I keep thinking this is so patently ridiculous, there must be something else going on here, like a trade-off for lower 510(k) fees.  No, not thinking...just hoping.

    ------------------------------
    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


  • 13.  RE: De Novo Summary ODE 2015-2018

    Posted 08-Nov-2019 11:53
    Good question about the effect of the high user fees on De Novo submissions.  It made me curious.  It does appear that the number of submissions filed for De Novos decreased after the 2018 user fees went into effect.  There were 92 submitted in 2017 and only 69 in 2018.  Too early to tell for 2019, and the numbers could change for 2018 as new approvals come through.  

    Posted a graph if you want to see it over time - https://www.graematterintel.com/oneclickdevices

    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC, FRAPS
    St Louis MO
    United States
    ------------------------------

    Original Message


  • 14.  RE: De Novo Summary ODE 2015-2018

    Posted 08-Nov-2019 15:46
    Thanks, Melissa.  I'm a stat geek, so numbers always appreciated!

    I'm tracking them by date of decision, rather than submission.  How did you pull the submission dates?  FDA's De novo database doesn't have them, as far as I know, meaning they are only available to be extracted from the PDFs, not as database data.)

    ------------------------------
    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


  • 15.  RE: De Novo Summary ODE 2015-2018

    Posted 11-Nov-2019 18:32
    Julie,
    On the FDA De Novo website page (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm) the submission dates can be found in the individual record.  The export to Excel function only includes some data.  
    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
    ------------------------------

    Original Message


  • 16.  RE: De Novo Summary ODE 2015-2018

    Posted 11-Nov-2019 18:58
    Thanks, Melissa, That's what I thought.  I have mixed feelings in having you confirm this.  On the one hand, I'd be thrilled if I didn't have to extract them manually going forward.  On the other, I'd feel like a complete idiot for having spent untold hours on manual extraction, if I could have just exported them!

    ------------------------------
    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


  • 17.  RE: De Novo Summary ODE 2015-2018

    Posted 01-Mar-2020 13:50
    It seems that it's the number of submissions per month that tell the tale.  The spike in submissions in 2017 was not actually in 2017, but in September of 2017.  And it was a big one, relative to other months.

    It also seems that, in 2018, the average number of submissions per month increased a fraction over average monthly submissions in 2016. Any additional decisions posted for De novos submitted in 2018 can only increase this fraction. 

    2019 will be very interesting, but we won't get a good look at it for at least another year.  I hope I can stand the suspense. :)

    ------------------------------
    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


Related Content