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this post was submitted on 30 Jan 2024
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Microblog Memes
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If you’ve ever dealt with getting a medical device approved by the FDA, you’d know they don’t fuck around. They’re so hardcore it’s scary.
Not when you're the wealthiest person in the world. All hurdles are trivial when you're wealthy.
In my experience, I've seen a muti billion dollar company denied new product testing for errors on paperwork.
My former employer had to etch "not for human use" in the devices because the FDA didn't clear them. They took them to use on sheep instead.
The FDA, as long as it doesn't fall prey to the revolving door like every other regulator, is extremely effective.
there are ways around them. convince them your product is "substantially equivalent" and they don't look too hard, apparently. (see - hard silicone penile implants)
https://www.propublica.org/article/penis-enlargement-enhancement-procedures-implants