this post was submitted on 22 Sep 2023
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FDA approval ain't evidence that something is safe. See the recent approvals for anti-Alzheimers meds that have a terrible side-effect to benefit ratio.
For sure, that's what the testing is for. Now that a device has been put in a human it will be determined if it's safe over many years and trials.
If something is dangerous in animal testing, it shouldn't reach humans. The FDA is toothless (due to underfunding and regulatory capture).