"The primary advantage of the PDS process is that it provides an early opportunity to obtain our assessment of the suitability of a new device for the de novo process, our preliminary perspective on the likely classification, as well as feedback on the evidence, including performance and/or clinical data, that will likely be necessary to support the de novo petition."
I really want to like the new de novo guidance, but I suspect I'm going to hate the pre-de novo submission (PDS). You can see FDA's heart is in the right place, but I think they just messed the whole thing up.
OIVD uses the de novo pathway more than any other CDRH group, so my experience is with IVD products. OIVD has been using the "pre-IDE" mechanism to discuss a whole range of questions including whether a product is eligible for a de novo submission. After discussing options at a pre-IDE meeting, OIVD advises on whether a traditional 510(k), a de novo 510(k) or a PMA is the best route. The information gathered at these early meetings isn't just about whether a de novo path can be followed, it includes discussion on many issues including intended use statements, analytical and clinical study requirements as well as the appropriate regulatory pathway.
By creating another early-stage submission which does not even mention the current pre-IDE mechanism, I fear that we now will be required to pursue both types of applications in order to get our early questions answered.
Let's work with an example. If you have a device with no predicate that you believe is moderate risk, what should you do? Well... for starters, there's no predicate, so you should be a bit circumspect about deciding that you know what its classification will be. That's the kind of thing that an early meeting with FDA should help resolve, right?
Yes... but which early meeting should you set up?
You're hoping for a de novo, so maybe you should submit a PDS. But it appears that a PDS is only the front-end decision-making process for a de novo submission. If you don't get the classification you want, it looks like you're back at the beginning of the process and must submit a pre-IDE. It's going to feel like you just waited in the wrong line at the DMV.
On the other hand, you want to make sure you cover your bases, so maybe you should submit the more traditional pre-IDE. But does that have the risk of tacit admission that a PMA is the likely outcome? Or maybe after the pre-IDE now we have to go through the formal PDS process to ensure the de novo pathway?
The document is a draft and hopefully, there is still time to build a bridge from a PDS to a pre-IDE (or avoid one of them altogether). I strongly urge FDA to pursue the path of making existing pathways more efficient and not create new types of applications that blur the decision-making process. OIVD already does this quite well; the rest of FDA should endeavor to understand what they've already figured out rather than impose some new process on a perfectly good one.
