Comment by inglor_cz
2 days ago
Surgeries aren't regulated in the same way that drugs are, though. AFAIK the bureaucratic threshold for experimental surgeries is much lower.
2 days ago
Surgeries aren't regulated in the same way that drugs are, though. AFAIK the bureaucratic threshold for experimental surgeries is much lower.
You'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.
What about the Breakthrough Device Designation or the Investigational Device Exemption?