This training offered by the Human Research Affair’s Institutional Review Board (IRB) Department serves to provide guidance to clinicians pertaining to emergency and non-emergency uses of investigational drugs and devices in the setting of treatment of a single patient. The training reflects the expectations and requirements set forth in the Code of Federal Regulation 21 CFR 312.300, 21 CFR 312.305 and  21 CFR 312.310 for the expanded access use of drugs and the FDA’s guidance on expanded access for medical devices, including elements of 21 CFR 812 that pertain to expanded access use of investigational devices in individual patients.