Experience with De Novo applications

Dobby1979

Involved In Discussions
#1
Hi All.

Does anyone have much experience with De Novo applications? Do you have any learning points or pearls of wisdom that could be shared?

Did you engage with any consultants to verify your application / guide you along the way? Would you recommend this?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
As a consultant, I strongly recommend you engage one... :lol:

I have limited experience with the current De-Novo process. My recommendations are quite generic - make sure to learn the current issued FDA guidance and consider using the pre-sub provisions.
 

Watchcat

Trusted Information Resource
#3
Since FDA published the draft guidance in August 2014, it has granted a little over 100 "direct" De novos that were submitted after the guidance was issued, and only a few dozen since the final guidance was in October 2017. The process is still not finalized. FDA posted a Proposed Rule for comments earlier this year.

So, not much experience to be found out there, possibly none here on Elsmar Cove. Moreover, it's not clear how much past experience will apply to future De novos, or how much experience with any given De novo will translate to another, since they are...well, De novo. To the extent they are truly novel devices (and this remains to be seen), you need to figure things out for yourself, with no predicate to guide you. The existing experience with truly novel devices is with original PMAs, rather than with 510(k)s, and this experience is also not that common within the industry.

I have been following the De novo process since before the draft guidance was issued. Early on, I spoke with several FDAers about the process and also to a number of RA professionals who had done a De novo. Those who had worked on PMAs thought the De novo was a walk in the park. Those who had worked only with 510(k) devices had mixed experiences.

I am currently working on some high-level analyses of the De novos that had made it though FDA as of December 31, 2018. It is very slow going, because the FDA's databases are pretty clunky. In addition, the sample size is still too small to make it useful for anything but a high-level analysis at this point. When I get an analysis completed, I will post it to Elsmar Cove. I have split out ODE and IVDR De novos, and should have some very basic statistics on the ODE De novos available in the next 2-3 weeks.

I have not taken a De novo through FDA yet. Getting old, and at the rate they are going, might never. I have developed a few regulatory plans and one pre-submission packet, mostly for startups, which is to say, mostly for devices that will probably not make it from initial plan to market, sigh.

Tips:

1. It's all about the risk. (So much so, that by now I have a song in my head set to Meghan Trainor's "It's All About That Base," which finishes, "...no benefits.") This was the first early wisdom to emerge, probably based more on a reading of the guidance than experience. As it turned out, per FDA, it was the actual classification that was the most common stumbling point encountered with early experience. Not surprising, since (no matter what they tell you) neither FDA nor industry has much experience with classification. (510(k) devices are essentially "pre-classified," based on the predicate.) This has probably improved lately, especially on FDA's side.

2. Do a pre-sub meeting. Absolutely, positively.

3. Get an experienced consultant. Really. It's hard enough for a device startup to make it without one. A consultant with De novo experience might be great, but experience in the therapeutic area, and maybe with the technology (e.g. imaging, software, IVD) can be as important. What you need most, IMO, is substantive premarket experience with FDA, beyond that which you will get by filing some bench tests to show equivalence to a "me too" predicate. Experience with 510(k)s that require clinical trials, De novos, or PMAs.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#4
3. Get an experienced consultant. Really. It's hard enough for a device startup to make it without one. A consultant with De novo experience might be great, but experience in the therapeutic area, and maybe with the technology (e.g. imaging, software, IVD) can be as important. What you need most, IMO, is substantive premarket experience with FDA, beyond that which you will get by filing some bench tests to show equivalence to a "me too" predicate. Experience with 510(k)s that require clinical trials, De novos, or PMAs.
Hmmm... Yourself?...
 

Watchcat

Trusted Information Resource
#5
RonenE, it could happen. As I'm sure you know, lot of things factor into a choice of consultants, as well as the decision to use one. Money can sometimes be a strong determinant. ;)
 

mihzago

Trusted Information Resource
#6
I have a De Novo for two products under my belt and worked with a few companies preparing for one (assisting with pre-subs and putting together the documentation). I don't think a direct experience with De Novo process is as important as extensive experience in the clinical/technical area, and also experience with complex 510(k) submissions. What I mean by that is a 510(k) with clinical data, adding new indications or pushing the intended use boundary.
FDA will review every claim in excruciating detail and ask for extensive data supporting these claims. Imagine a bunch of Ph.Ds doing their dissertation.
 

Watchcat

Trusted Information Resource
#9
Reassuring to see that mihzago and I are consistent in our perspective on the types of experience that are likely to be a good fit. The other problem you are likely to face is that so much FDA device RA work involves "non-clinical" 510(k)s, the fact that you don't need to limit yourself to someone with prior De novo experience still doesn't give you a huge pool of consultants to choose from, and those who have this background are not likely to be sitting around with nothing to do. So you will want to plan well ahead. IMO, if you have your risk analysis and your user requirements and no RA consultant, you are now officially running behind on RA consulting. But, as an RA consultant, I would think that.

A lot of my clients these days are novice (academic researchers or practicing clinicians with a bright idea). If they find me early, and they have a truly novel technology, I like the idea of an informational meeting even before a pre-sub, to introduce FDA to the technology and, equally important, the novices to FDA. But these are low priority meetings for FDA, so it can take awhile to get one. Otherwise, if timeframes allow, I'm inclined to focus on the pre-sub, and not worry so much about the submission. Of course, if the startup didn't start looking until they thought they were ready to submit, and think that they just need someone to "compile" the submission...well, I would say it is too late for the pre-sub, but sadly, it is often too late to have found an RA consultant. Then they have to back up to the pre-sub, which is where they learn they weren't ready to submit after all. :(
 
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