FDA stuff is not well understood.
If you are running trials for FDA APPROVAL of a Class III medical innovation then it takes years, many failures, and lots of money.
But a 510(k) FDA CLEARANCE for a Class II Medical Device is usually just a process with a base timeline plus any toing and froing between applicant and FDA.
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
https://www.goodrx.com/healthcare-access/medication-education/fda-approval-vs-fda-clearance
...
Ann: September Quarterly Activities Report, page-18
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