Emergency Use of an Investigational Drug/Device
Step 1: Complete the Checklist
...to determine whether the use of the
drugDrug1) a substance recognized by an official pharmacopoeia or formulary; AND
2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND
3) a substance (other than food) intended to affect the structure or any function of the body; AND
4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device.
Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).
deviceDevicean instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, OR 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Emergency UseEmergency Usewhen an unapproved drug or device is used to treat a patient in an emergency situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval. Emergency means life-threatening (drug & device), severely debilitating (drug), or serious disease or condition that needs immediate treatment (device). .
Select the appropriate checklist:
Step 2: Use the Drug or Device
informed consentInformed Consenta person's voluntary agreement based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic therapeutic or preventive procedure.
(or statement from independent physician) you may proceed with treating the subject.
Select the appropriate document:
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:
Need more guidance? Click here for a detailed description of the Emergency Use Process.
Contact the OIRB
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
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