Comment by jasonjmcghee

My interpretation of what I've read of "off-label" medical device use... is that I don't think that's true at all. But IANAL or medical professional.

https://human.research.wvu.edu/fda-regulated-devices-used-in...

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9. Does FDA require IRB review and approval of off-label use of a legally marketed device?

...(unrelated for this conversation)...

Yes, when the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required (21 CFR 812.2(a)). For additional information on the off-label use of devices, see the FDA Information Sheet guidance, “ ‘Off-label’ and Investigational Use of Marketed Drugs, Biologics and Medical Devices.”