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-approvedBy 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-deviceI 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-differencesGetting 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.
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