Ann: Quarterly Results Webinar, page-31

Craig said something in relation to the FDA 510(k) Pulse Clearance in the conference call which was a bit of a "duh" moment for me.
He said something along the lines of : depending on what level of clearance we get, RX or ..... ( I think he said OTC / Over the Counter ).

A clearance for a medical device simply means it is cleared for use under certain conditions.
RX - Prescription Only ( think of contact lenses or hearing aids )
OTC - Over the Counter ( think of a pregnancy test, or a standard BP monitor )

Many are cleared for use by clinicians, but cannot be used in the home at all ( think of anything you have to go to a diagnostics type clinic or hospital to get done ).

I have been attempting to educate myself on requirements of the FDA for classification.
This was the best source of info I found : https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers

Our previous devices have been for use in a clinical setting.

The Oscar 2 Device by SunTech is an Ambulatory Device ( 24hr monitor, setup by the clinician )
https://www.suntechmed.com/bp-products/ambulatory-blood-pressure-monitoring/oscar-2-ambulatory-blood-pressure-monitor

So from my understanding, the Pulse is the first device CardieX will have for in-home use, either prescribed by a clinician, or purchased OTC.
It's not a simple replication against previous acceptance, as we have to meet a new set of criteria which is about "layman" understanding of application of Pulse, use of Pulse, interpretation of data from the Pulse etc. I'm sure this will explain the length of time the process is taking. We will get clearance IMHO, put with what "classification" is the unknown.

It obviously has a significant impact on how we go to market.
A) If it has to be prescribed, then it is all about clinical trials, use by GP's and the leasing model via clinicians.
B) If it is OTC, then we can sell directly to the likes of Walmart.

I do note that at the AGM etc all go to market discussions were referencing A), and in hindsight it is obvious why. CDX Mgmt are confident of achieving A), but as for B), not so sure on this iteration. If we do get B), then the likes of Walmart meeting with us at CES23 could have some serious market ramifications.

If we get RX designation, it does not prevent you for applying for OTC designation at a later stage.

I came across a couple of sites assisting companies achieve OTC designation for their medical device, some insights as to extra information requested by the FDA examiner during the process. I remember seeing extra spend in the 1st QTR against additional regulatory process, wouldn't be surprised if we were asked for something similar.

HF validation test (if deemed necessary based on your use-related risk analysis), or potentially as a standalone test. In our experience, despite the lack of specific guidance, the FDA has sometimes requested that OTC medical device and combination product manufacturers perform a self-section study. Such a request might come about because the product is changing from a prescription to OTC status, there is no predicate, or there is a new indication. If the FDA has specifically requested a self-selection study, we highly recommend having discussions with the agency to fully understand their expectations – for example, a statistically powered study in strict compliance with the OTC self-selection study guidance might not be necessary, but rather a study loosely based on the guidance might be sufficient.Either way, here are a couple of extra things to consider when conducting a test to evaluate self-selection:Include participants with varying levels of literacy, in particular individuals who have been assessed (e.g., via the Rapid Estimate of Adult Literacy in Medicine (REALM) test) to have low literacy skills (also applicable for label comprehension studies)Include participants who have contraindications to use the product, potentially targeting a specific population of interest depending on the identified risks and study objective.

Anyway, a bit of a ramble, but hopefully it is of some use in understanding what is going on.

IMO
DYOR