RE: If it is true the FDA accept "real world" data from the likes of the NHS11 Sep 2025 12:27
Slacker.
"They haven't got the money for FDA application...simple!!!!!"
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Does not sound that expensive to me:-
For medical devices, a 510(k) submission can cost around $30,000 to $44,000, though this doesn't include preparation costs, which can add $20,000 to $25,000 or more.
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I believe NOT doing this was/is a monumental error by the Directors. They should do everything they can to get it submitted asap!!!