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Surgeries aren't regulated in the same way that drugs are, though. AFAIK the bureaucratic threshold for experimental surgeries is much lower.
by inglor_cz 2y ago
Surgeries aren't regulated in the same way that drugs are, though. AFAIK the bureaucratic threshold for experimental surgeries is much lower.
- derektank 2y agoYou're entirely correct. I was trying to speak about medical therapies generally but the FDA doesn't regulate surgical techniques. Some new surgical techniques do require experimental medical devices which would require FDA approval though. And you still have to deal with the bureaucratic hurdles of acquiring grants for clinical trials and getting insurers to cover treatments of course, but it's certainly a lower barrier.
- hbarka 2y agoWhat about the Breakthrough Device Designation or the Investigational Device Exemption?