Even for an emergency use, the investigator is required to obtain informed consent of the subject or the subject's legally authorized representative unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

• 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.

If, in the investigator's opinion, immediate use of the test article is required to preserve the subject's life, and if time is not sufficient to obtain an independent physician's determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.The investigator must notify the IRB within 5 working days after the use of the test article.

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