Oiconomia@feddit.de to Microblog Memes@lemmy.worldEnglish · 5 months agoOh no the neural implant project backfired, I must now spread the logs throughout the building an leave a distress message in Latinfeddit.deimagemessage-square202fedilinkarrow-up11.66Karrow-down123
arrow-up11.64Karrow-down1imageOh no the neural implant project backfired, I must now spread the logs throughout the building an leave a distress message in Latinfeddit.deOiconomia@feddit.de to Microblog Memes@lemmy.worldEnglish · 5 months agomessage-square202fedilink
minus-squareNaN@lemmy.sdf.orglinkfedilinkEnglisharrow-up39arrow-down1·5 months agoFDA had denied, company presumably made some sort of changes that were not publicized (or paid off the right people), FDA approved.
minus-squareHootinNHollerin@lemmy.worldlinkfedilinkEnglisharrow-up31·edit-25 months agoIf 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.
minus-squarebraxy29@lemmy.worldlinkfedilinkEnglisharrow-up2·5 months agothere 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
minus-squareWanderer@lemm.eelinkfedilinkEnglisharrow-up1·5 months agoThey famously didn’t approve the wonder drug thalidomide.
minus-squareAwkwardLookMonkeyPuppet@lemmy.worldlinkfedilinkEnglisharrow-up7arrow-down13·5 months agoNot when you’re the wealthiest person in the world. All hurdles are trivial when you’re wealthy.
minus-squarepeopleproblems@lemmy.worldlinkfedilinkEnglisharrow-up27·5 months agoIn 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.
FDA had denied, company presumably made some sort of changes that were not publicized (or paid off the right people), FDA approved.
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.
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
They famously didn’t approve the wonder drug thalidomide.
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.