Emergency use of a test article

The following criteria must be met for emergency use of an investigational drug, biologic or device:

• The patient is facing a life-threatening and/or severely debilitating condition, for which there is no conventional/acceptable treatment. See how FDA defines "life-threatening" and "severely debilitating."
• There is insufficient time to obtain IRB approval prior to administration.
• The patient receiving the test article will not be enrolled in a research study involving the test article.
• The investigator has legitimate access to a test article and believes that there is reasonable likelihood that its use may be advantageous to the life-threatening condition.

There are other similar uses, such as compassionate/expanded access for intermediate-size patient populations and for larger patient populations, but they require prior IRB and FDA approval. These may not be considered an emergency situation. Please consult the manufacturer/sponsor and the IRB. See the Investigational, Compassionate, Emergency and Humanitarian Use SOP for additional information.

The FDA permits emergency use of a test article (e.g., investigational drug, biologic or medical device) on a patient in a life-threatening situation in which:

• No standard acceptable treatment is available.
• There is insufficient time to obtain IRB approval.  

Although prospective IRB approval is not required for emergency use per FDA regulations, investigators are highly encouraged to reach out to the IRB for guidance. The criteria for emergency use must be met and must be reported to the IRB promptly within five working days of use. 

See below for a brief summary of emergency use requirements. Please review the section about emergency use in the Investigational, Compassionate, Emergency and Humanitarian Use SOP for more details. 

Requirements for emergency use of an investigational device exemption (IDE)

Using an investigational device with an IDE

Emergency use may apply if the investigational device is being studied in a clinical trial under an IDE if:

• An investigator needs to use the device in a manner inconsistent with the approved investigational plan OR
• An investigator who is not part of the clinical study wishes to use the device to treat a patient with a life-threatening or serious disease or condition. 

If using an investigational device, the investigator must obtain authorization from the sponsor of the IDE. 

If there is an IDE for the device, the IDE sponsor must notify the FDA of the emergency use within five days through submission of an IDE report. This follow-up report should include:

• A summary of the conditions constituting the emergency.
• The patient protection measures that were followed.
• Patient outcome information.

Using an investigational device without an IDE:

Emergency use of an investigational device may occur before an IDE is approved and when a device is not being studied under an IDE. 

If no IDE exists, the investigator should submit to the FDA a follow-up report within five days of the use of the device, including:

• A description of device used.
• Details of the case.
• The patient protection measures that were followed.  

Submit the report to:

Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Ave
Document Control Center
WO66 Rm. G-609
Silver Spring, MD 20993

Patient protection measures

For emergency use of an investigational device, the investigator should follow as many patient-protection measures as possible. This includes obtaining:

• Informed consent from the patient or a legally authorized representative.
• Clearance from the institution as specified by institutional policies.
• Concurrence of the IRB chairperson.
• An independent assessment from an uninvolved physician.
• Authorization from the IDE sponsor if an IDE exists for the device.

Learn more about investigational devices on the FDA website.

If consent is not obtained from the patient or their legally authorized representative, both the investigator and a physician who is not otherwise participating in the emergency use must certify in writing all of the following conditions:

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

This information must be uploaded with the Emergency Use of a Test Article Form.

Exception: If, in the investigator's opinion, immediate use of the test article is required to preserve the patient's life, and if time is not sufficient to obtain an independent physician's determination that the above four conditions apply, the investigator should make the determination and within five working days after the use of the article, have an independent physician review and evaluation the determination in writing.

Promptly contact the IRB and submit an Emergency Use of a Test Article Form in eCompliance.

If emergency occurs during normal business hours, please call the IRB at 573-882-3181 or e-mail muresearchirb@missouri.edu for consultation. 

If it's not possible to contact the IRB in advance, the investigator may administer the drug/biologic or device as long as:

• Informed consent from the patient is obtained (see above for consent requirements).
• An Emergency Use of a Test Article Form is submitted within five working days of the administration.   

A chair or IRB member designee will review the request for emergency use for acceptability if time allows. If review by the convened board is possible within the time available, it will be reviewed by the convened board. 

If the request is approved, a determination will be sent to the investigator through the eCompliance system. If there are concerns or questions about the use, the investigator will be contacted. The investigator will be asked to upload FDA documentation upon receipt.

Generally, once a test article is used in an emergency without prior IRB approval, any subsequent use would require prior IRB review and approval (§ 56.104(c)). If a subsequent use is expected, an investigator should request review and approval by the MU IRB after the initial emergency use by submitting an IRB application. 

However, When prior IRB review and approval is not feasible for a subsequent emergency use, FDA states it does not intend to deny the subsequent request for emergency use based on lack of time to obtain prospective IRB review as long as that use will be reported to the IRB within five working days of initiation of treatment (§ 56.104(c)).

The FDA determines whether they will continue to permit repeat emergency use of the same drug/device by the same investigator. They may request the investigator initiate a full IRB submission for approval (this is recommended by the MU IRB if you anticipate future use). We recommend engaging the FDA and sponsor/manufacturer in advance, when possible, if you anticipate the potential for future use with new patients.