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Emergency Use of an Investigational Drug or Device

From the FDA Information Sheets, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update.

FDA defines the emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. [21CFR 56.102(d)]

FDA Emergency Use Guidance

Obtaining an Emergency IND

Exemption from Prospective IRB Approval

Exception from Informed Consent Requirement

Humanitarian Device Exemption (HDE) Regulation: Questions & Answers

 

 

 

 

 


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