Seeking a De Novo Consultant


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Does anyone know a consultant who has experience with De Novo device submissions? We are backed up with EUAs and need help.
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The Cheerful Diabetic
I haven't known anyone who has submit a De Novo device. There is so much predicate now, that it's pretty rare! Hopefully you can get some guidance on this - I'm curious :p


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Does anyone know a consultant who has experience with De Novo device submissions?
I haven't known anyone who has submit a De Novo device.
That's probably because FDA has only issued some 150 direct De novos since it first published its draft guidance in August 2014. If you exclude all the RA professionals who submitted a De novo as an employee of the manufacturer and unavailable due to still being their employee, that narrows the field quite a bit. If you don't want to pay the rates charged by consulting firms, law firms, and CROs, that narrows it further still. If you want someone with prior experience with a particular therapeutic area or technology (e.g., SaMD, IVD, radiology), your pickin's get pretty slim. Add to that someone who is available reasonably soon, slimmer still.

Norm, my experience is with PMAs, and they don't call the De novo a "mini-PMA" for nothing. Nor is it coincidence that most of FDA's Proposed Rule for De novos is lifted verbatim from the PMA regs. If you don't find anyone, you might consider expand your search to people with PMA experience. If you do, I'd be happy to speak with you.


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Also, over half of the De novos submitted in 2015 and 2016 (54% and 60%, respectively) remained unaccounted for at the end of 2019. So keep in mind that, just because they've had experience, doesn't necessarily mean it was a good experience. :(


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De Novos for stand alone software are quite common, unfortunately many get bogged down with data requests from the FDA. Many companies start with an idea of De Novo but then pivot to simpler claims to gain a 510(k) first.
I have been involved in a few as a consultant, but also have 'double de novo' completed on my own.
I can also recommend EBG Law/Advisors Overview FDA Regulatory | EBG Advisors, Inc. if you're looking for larger consulting firm.


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Where can I see this information!
You have to calculate the percentages yourself, but it's not that hard.

Go to FDA's De novo database. Search for all De novos posted after 01/01/2015. For each year of interest, look at the highest DEN number CDRH assigned for that year (all the 170000s were received in 2017.)

Then look at the last two digits of the DEN numbers. Because CDRH assigns DEN numbers in the order received, you can assume the highest number is the total number of De novos it received that year. (It's possible that 1 or 2 were assigned after the last one posted and are not posted because they failed. But that's not going to make a big difference in the outcome.)

Then count the total number CDRH has posted for that year. That is the number that were successful. Subtract that from total received, and that is the number that almost certainly failed. (It is possible that 1 or 2 are still slugging their way through review, but, again, that's not going to make much difference in the outcome. Plus, a De novo submitted to FDA prior to 2018 and still slugging its way through review is arguably a failed DEN novo, too, even if it finally makes it out the other side. It's just a different kind of failure.)

You can also do the same for 510(k)s and PMAs, if you want to compare.
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