This is absolutely my question as well - curious if it's legal to do this, I'm guessing yes as it's an existing ultrasound device? But is there possibility of permanent damage?
It's objectively cool, but very curious about the safety as well.
It's objectively cool, but very curious about the safety as well.
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.”