Given there is ongoing discussion around FDA it is worthwhile...

Given there is ongoing discussion around FDA it is worthwhile ensuring you are clear on the FDA classifications:
People use the terms Clearance/Approval/Registered/Listed etc - often without fully understanding the differences.

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved


By the way, the term "Registered" seems to only apply to registering of a company, and "Listed" implies no level of classification.



Its also important to look at whether the device being put to the FDA is Class I, II or III device.

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

I would assume that our devices are at most Class II, possibly Class I - I'm sure its written somewhere.



https://www.qualio.com/blog/fda-medical-device-classes-differences

Getting a Class II Medical Device "Cleared" (or "Granted") is not an onerous task.

One of my other stocks is currently doing fairly simple Clinical Trials for a device and the timeline is roughly 3 months, done here in Australia.

Results of these Clinical Trials will then be submitted to the FDA, in this case under DeNovo rulings, to be "granted" a "Clearance".

I hope that helps.

...