Emergency Use Device
Notification of Emergency Use
Emergencies may arise where an unapproved device may offer the only possible life-saving alternative, but an IDE for the device does not exist, or the proposed use is not approved under an existing IDE, or the investigator or institution is not approved under the IDE. If an IDE for the use exists, authorization form the sponsor must be obtained. If an IDE does not exist, the FDA
must be notified with a written summary of the conditions constituting the emergency, subject protection measures, and results. Each of the following conditions must exist to justify emergency use:
- The patient is in a life-threatening conditions that needs immediate treatment;
- No generally acceptable alternative for treating the patient is available; and
- Because of the immediate need to use the device; there is no time to use existing procedures to get FDA approval for the use.
Subsequent use of the investigational product requires IRB review and approval.
For an emergency use, the investigator is required to obtain informed consent of the subject or the subject’s legally authorized representative. If the sponsor has an existing consent form, that form may be used. If there is no existing consent form available from the sponsor, a clinical consent form should be used. An exception from the informed consent requirement may be obtained if the following is certified in writing:
- The subject 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 subject.
- Time is not sufficient to obtain consent from the subject's legal representative.
- No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.
The investigator shall notify the IRB of the emergency use via phone at 513-558-5259 or email (firstname.lastname@example.org) within 5 days after the use of the test article. The investigator must submit an Emergency Use submission in ePAS after the notification.
Note: All investigators will need to gain access to ePAS in order to submit through the electronic system. (Click here for ePAS instructions).
Emergency Use Review Process