Test articles given to human subjects under a treatment IND or IDE require prior IRB approval, with two exceptions. If a life-threatening emergency exists, the procedures described in 56.104(c) ("Exemptions from IRB Requirement") may be followed. In addition, FDA may grant the sponsor or sponsor/investigator a waiver of the IRB requirement in accord with 21 CFR 56.105. An IRB may still choose to review a study even if FDA has granted a waiver.
