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Emergency Use of an Investigational Drug/Device

Step 1 puzzle piece image

Step 1: Complete the Checklist

...to determine whether the use of the drug or device qualifies as 
Emergency Use.

Select the appropriate checklist:

Step 2 puzzle piece image

Step 2: Use the Drug or Device

…after obtaining informed consent 
(or statement from independent physician) you may proceed with treating the subject.

Select the appropriate document:

Step 3 puzzle piece image

Step 3: Notify the IRB

...within 5 days of use, 
the IRB must be notified of the use.

Submit these to the IRB via IRBMail@uthscsa.edu:

  • 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.

Policy

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