Office of the Institutional Review Board

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Emergency Use of an Investigational Drug/Device


Complete the Checklist	Use the Drug or Device	Notify the IRB
...to determine whether the use of the drug or device qualifies as Emergency Use.	…after obtaining informed consent (or statement from independent physician) you may proceed with treating the subject.	...within 5 days of use, the IRB must be notified of the use.
Select the appropriate checklist:	Select the appropriate document:	Submit these to the IRB via IRBMail@uthscsa.edu:
Drug Emergency Use Checklist Device Emergency Use Checklist	Informed Consent Template Independent Physician Certification	IRB Notification Form FDA EIND Letter (applicable to drug only) Informed Consent OR Certification (see step 2) Drug Checklist OR Device Checklist (see step 1)
Need more guidance? Click here for a detailed description of the Emergency Use Process.

Guidance / Policies / Regulations
UTHSCSA IRB Guidance and Policy Emergency Use Process Guidance Emergency Use of an Investigational Drug or Device Policy and Procedure FDA Guidance and Regulations: 21 CFR 50.23 – Exception to informed consent 21 CFR 56.102(d) – Emergency Use definition 21 CFR 56.104 – Exception to IRB review 21 CFR 312.300 (Subpart I) - Expanded Access to Investigational Drugs for Treatment Use 21 CFR 812.35 – Exception to IDE requirement Emergency Use of an Investigational Drug or Biologic [FDA] Form FDA 1571 and Instructions - Investigational New Drug Application Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors - Frequently Asked Questions About Medical Devices Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use IDE Early/Expanded Access [FDA] - Emergency Use of Unapproved Medical Devices Medical Devices- Guidance on IDE Policies and Procedures [FDA] - Guidance on IDE Policies and Procedures