Are De novos failing?

Watchcat

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#1
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. This was in stark contrast to 510(k)s and PMAs, both of which have pretty good success rates.

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

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Mark Meer

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#2
Hi @Watchcat,
I'd very much be interested in your analysis, as we may be considering a future DeNovo.
Are you planning to write up your findings somewhere I can follow?
Also curious: is there any indication/break-down as to why so many apparently fail?

MM.
 

Watchcat

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#3
Huh. Well, it was attached last time I looked. Let me try again....

OK, should be there now. Maybe when I was looking, I forgot to Save.
 
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Mark Meer

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#4
Thanks for sharing @Watchcat! Interesting.

I wonder to what extent there might be multiple (duplicate) submissions - i.e. several companies come up with, for example, a novel indication and all submit DeNovos at around the same time...all of which are ultimately rejected. As you point out, with no way to tie these to subsequent PMAs, we'll never know, but it is another reason why it'd be nice if FDA could maintain some public data on rejected applications.

...And how many might have been submitted by companies that failed to provide CDRH with adequate information on which to base its feedback, or simply lacked the capacity to understand and follow the feedback they were given.
Perhaps I'm also only "look[ing] from my little tide pool", but I'm skeptical as to how much of the apparent DeNovo rejections would be attributed to companies not heeding or "lack[ing] capacity to understand" direct FDA pre-sub feedback. ....otherwise they'd be completely undermining the purpose of pre-sub. I would expect that most companies going through the pre-sub process would have the wherewithal to actually use the feedback garnered...
 

Watchcat

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#5
there might be multiple (duplicate) submissions
Another possibility, and there are probably others, but without transparency, doesn't seem useful to spend a lot of time coming up with yet more.

I'll be interested to see if anything changes once there is enough data to look at probable failure rates for a few more years. These two years were "early days" in terms of a learning curve for both industry and CDRH, the draft guidance having been only issued in August 2014. It will also be interesting to finally see failure rates for De novos submitted after user fees were imposed. I'm not clear how user fees might impact De novo failure rates, but it seems like an obvious question to ask.

Of course, if you are planning to submit a De novo any time soon, these later data won't be of much help.

it is another reason why it'd be nice if FDA could maintain some public data on rejected applications.
I would like to work towards that, but it would take people from industry stepping up to say that posting basic information, like DEN#, date of submission, date of resolution, and the nature of the resolution (withdrawn, rejected, subsequently reviewed as 510(k), PMA, etc.) will not threaten their "confidential and proprietary" information, and at times would even be helpful.

But this seems to be an industry that doesn't often speak up for itself, leaving a void that others rush in to fill. Which might be okay, except that it's not clear to me that these others actually know that much about the industry or what is likely to best serve its interests.

Perhaps I'm also only "look[ing] from my little tide pool", but I'm skeptical
I'm thinking there are not a lot of "innovative" startups in your tide pool? Definitely no shortage of those that do not heed and/or lack the capacity to understand. Except I wouldn't normally expect this crowd to pursue a De novo, more like run away from one as fast as they can. Still, the total number of "failed" De novos in 2015 and 2016 was only around 70, so perhaps some number of these were exceptions that prove the rule.
 
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