Why is the IRB involved in overseeing a treatment/diagnostic device?
Because of the unique situation in which an untested device is being used, the FDA regulations require the added protection that the HUD can only be used if the facility’s IRB has approved the use. (21 CFR 814.124) In its most recent guidance on the topic, the FDA now recommends that the IRB conduct a full board review at its initial consideration, though expedited review may be appropriate for continuing review.
