Emergency Use

Overview

Emergency Use is the expanded access treatment with an investigational drug, biologic or medical device when a patient is in a life-threatening situation in which no standard acceptable treatment is available and where there is not sufficient time to obtain IRB approval.

FDA defines life-threatening and severely debilitating as follows:

The emergency use provision under 21 CFR 56.104(c) is an exemption from prior IRB approval for the emergency use of an investigational medical product. Planned subsequent treatment with the investigational drug/biologic or device should be submitted to the IRB for prospective approval, when possible.

Notifying the Stanford IRB

The IRB should be notified of the Emergency Use within 5 working days following treatment by emailing the following to secure-irbemergencyuse@lists.stanford.edu:

1. Completed and signed Emergency Use- IRB Notification Form (with Section D completed and signed by an independent physician if consent was NOT obtained),
2. Copy of the signed consent form (if consent was obtained), and
3. FDA documentation (email is sufficient) authorizing the Emergency IND for treatment with a drug/biologic, OR written permission from the device manufacturer for the use of the device for treatment with a medical device.

The IRB will review the information and issue a signed confirmation of Exemption from IRB Review to the treating physician.

Consent

Informed consent for emergency treatment should be obtained in accordance with FDA regulations under 21 CFR 50.20. Use the Regular Consent with HIPAA template, revising the consent form to reflect the expanded access treatment program and removing references to "research".

Exception from Informed Consent for Emergency Use

FDA regulations under 21 CFR 50.23 allow for an exception from informed consent when both the treating physician and an independent physician who is not otherwise participating in the treatment, certify (in writing) that:

1. The patient is confronted with a life-threatening situation necessitating the use of the test article.
2. Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject.
3. Time is not sufficient to obtain consent from the subject's legal representative.
4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.

Other Considerations

Note that other Ancillary & Institutional Reviews may still be required for Emergency Use treatment.

FDA Information for Emergency Use with Drugs/Biologics

Emergency treatment with an investigational drug/biologic requires FDA approval prior to treatment.

In addition to the criteria for all Expanded Access Programs, for emergency use, the following additional criteria must be met:

• The physician must determine that the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition; and
• The FDA must determine that the patient cannot obtain the drug under another IND or protocol.

When there is no existing IND, a new Emergency IND may be sought by the treating physician. If there is an existing IND, the IND sponsor can submit a new protocol to the existing IND that describes the emergency treatment.

If Form 3926 is submitted to the FDA for an emergency individual patient IND request, section 10.b of this form should be left unchecked. This field is only intended to request concurrence by an IRB chairperson as an alternative to full IRB review when prospective IRB review is required for non-emergency individual patient expanded access.

Approval (for both a new IND and a protocol submitted under an existing IND) may be sought initially by phone, email or fax and treatment may start immediately upon FDA approval. A written submission should be submitted within 15 business days of the initial approval.

FDA Information for Emergency Use with Devices

Emergency treatment with an investigational device does not require prior FDA approval. 

The FDA expects the physician to assess the potential for benefit, have a substantial reason to believe that a benefit will exist, and to determine that the following criteria are met in addition to the criteria for all Expanded Access Programs:

• The patient has a life-threatening condition that needs immediate treatment;
• No generally acceptable alternative treatment for the condition exists; and
• There is no time to use existing procedures to obtain FDA approval for the use due to the immediate need to use the device.

The FDA recommends the physician should follow as many patient protections as possible, including:

1. Informed consent from the patient or a legal representative;
2. Clearance from the institution as specified by their policies;
3. Concurrence of the Institutional Review Board (IRB) chairperson;
4. An independent assessment from an uninvolved physician; and
5. Authorization from the device manufacturer.

The treating physician (or IDE sponsor if there is an existing IDE) must report the emergency treatment to the FDA within 5 days of the use of the device.

FDA Guidance and Contact Info

• FDA’s Expanded Access Contact Information
• Emergency Use of an Investigational Drug or Biologic – Information Sheet
• Expanded Access Categories for Drugs/Biologics
• Expanded Access for Medical Devices
• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

See Other Types of Expanded Access

Page updated October, 2025