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Stupid article. > Many diagnostic startup companies use this loophole to bypass the FDA’s rigorous clinical study and validation requirements which, on average
by piker 5y ago
Stupid article.
> Many diagnostic startup companies use this loophole to bypass the FDA’s rigorous clinical study and validation requirements which, on average, take three to seven years.
Then:
> Why didn’t any of the investors simply require Theranos to submit all their tests and the hardware platform to the FDA?