Since FDA published the draft guidance in August 2014, it has granted a little over 100 "direct" De novos that were submitted after the guidance was issued, and only a few dozen since the final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I have been following the De novo process since before the draft guidance was issued.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.