What's in the email when they're going to say yes? And what's in it when they're not?

Yeah.

And keep in mind, this is my own little empirical feelings about this.

But yeah, so when you submit your breakthrough, you will get some back and forth, what they call interactive review on email that I'm trying to understand.

And then I do find around that day 30, they will send you almost, it feels like an AINN in the 510k or de novo world but it's not as formal and it's usually by email still and they will ask you a whole bunch of questions trying to get to that final decision and so it'll be things about the data you submitted and about your arguments on improvement over standard of care If they are really big philosophical questions like, you know, we read this article and we think that you misunderstood this and we see this as not being an improvement.

You know, when they're challenging where they think it's not an actual improvement, this device out there does the same thing your device does.

You know, they'll say things like that and they'll question your data maybe about things.

Can this designation also be used for a kind of traditional 510k device?

Why is that route attractive and could it get a manufacturer in trouble?

first of all research use only product ruo i've kind of thrown that around and didn't really define it is product that's intended for for research use only you can't make any clinical claims about it there's two reasons for that it's for development of maybe product that's going to be going to fda and it's also there's also obviously as jesse will speak to there are plenty of research essays that are only really there for research.

And so it's just to detect a biomarker or a molecule, and there's no disease implications, any type of disease management recommendations, anything like that.

As you mentioned, and I mentioned before, this has been a general practice that IVD manufacturers will sell RUO reagents to CLIA labs.

And the CLIA lab may run it as an RUO, but they may also run it as an LDT.

And the difference being that LDTs, you report a clinical result.

So now what we're seeing, and this goes to be the FDA really hasn't gone away on the LDT issue and where we're seeing that is on the RUO reagent side.

What do you tell them about working with a lab without stepping over the line to looking like a test manufacturer?

Why do diagnostics get treated differently?

This is what you expect from wellness, right? What we've been talking about.

Apps that have the biomarkers that we've been talking about, like blood pressure, glucose, heart rate variability, you know, those kind of things we're all used to seeing.

For us at DCN, right, Emily, we, we get clients that have lateral flow assays, and these lateral flow assays are biomarkers, but you are bringing this test into people's homes.

And traditionally, everything, it's kind of like Blythe was saying on the other side, even, like, fertility tests and things like that were Class 1 even at home, and then most markers are Class 2.

So when FDA opened this Pandora's box with this guidance document and some statements that were coming from the uppers in FDA, I started getting all these clients saying, "Well, I want this intended use, and so it's gonna be wellness," right? And so being that FDA was, was kind of opening this up, I did some 513G requests for information, which it's going to FDA and saying, "I'm- We think this is not regulated because it's wellness, because this is our intended use.

And all of them so far have come back that you're a medical device still.

It'll be fascinating to see where it goes, I think, in the future, because there's so much opportunity and what they can do with machine learning algorithms now i-in terms of getting that data and connecting the dots to different things is pretty amazing.