For an IDE or IND the only exception I have seen is using an approved device for off label use. For example, our surgeons in the surgical procedures wanted to use hemostats to help move a nerve into a position to wrap a cuff around it. Surgeons have some leeway in the way they are allowed to use tools in their protocols.
If it was the surgeons who wanted to do it this way, instead of the sponsor wanting them to do it, I don't know that I'd call this an exception to the IDE, maybe more like outside of its scope. But maybe you are talking about a sponsor-investigator? (You say "their" protocols?)
Any IRB would suggest high risk and thus FDA oversight.
I'm afraid "any IRB" is something of a stretch.
But I don't think IRBs would need to worry about the risk, since, as far as I know, there is no NSR exemption from the IND regulations? In that case, since the drug is also investigational, the study would require FDA oversight regardless of the level of risk of the device, don't you think?
I worked at the Dept Veterans Affairs and managed several IDE studies. Almost every PhD had the IRB review require FDA oversight and a master file submitted to the FDA.
I've worked with federally funded trials, sponsored by federally funded organizations. I think they tend to hold themselves to somewhat different standards than are typically found in the industry. They may also operate under various policy and/or legal constraints that are not applicable to trials sponsored by industry.
You first need to demonstrate singularly to the FDA your device is safe and effective for its claims.
You mean before using it in a trial? I wouldn't think so. That's what you need to demonstrate in order to market it.
They could consent a population to use a non approved drug but you cannot legally consent to also an unapproved device as well.
I'm not aware of this prohibition. Is it part of the FD&C Act, or some other law?
