Just thought I would put it out there regarding terminology. When talking FDA
A Mistake I made as well in some earlier posts (apologies for any mis-terminology used)
It goes along these lines.
510(k) are clearances or cleared.
PMA are approved.
Denovo are granted.
Try not to interchange them.
Those a 3 of the 7 major pathways and many subpathways below them. And more than 20 overall pathways to bring a medical device to market in the USA.
Not investment advice, do your own research, and consult a licensed adviser.
Just thought I would put it out there regarding terminology....
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