ࡱ> PRO bjbj}} K#vvvvv8WKt>! -JJJJJJJ$L}OJv555JvvK5^vvJ5J@XFD;mZnRA(J'K0WKBDPPPFDFDPvZDh5555555JJ555WK5555P555555555 <:  SAINT LOUIS UNIVERSITY Institutional Review Board (IRB) INSTRUCTIONS FOR PREPARATION OF A HUMANITARIAN USE DEVICE (HUD) SUBMISSION Please do not submit these instructions with the protocol. The statute and the implementing regulation [see  HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=814.124" 21 CFR 814.124(a)] require IRB review and approval before a HUD is used, therefore, you must submit an application for review and it must be approved by the IRB before you can use a HUD. There is an exception to this rule for emergency situations in which the physician determines that approval cannot be obtained in time to prevent serious harm or death to the patient; please speak with the IRB staff for more information or see the emergency use guidance on the IRB web site. IRB Documentation Follow the outline and respond to sections A-J below. A sponsors document may be submitted if it contains all of the information below. Please insert labels to the appropriate sections. Each response should be numbered or labeled to correspond to each of the sections. The regulations do not require the facility where the HUD is used, the local IRB, or the local user to document that an approved HDE exists or that the device is to be used as specified in the HDE. However, the pro IRB requires that IRB approval of a HUD be contingent on IRB review of a consent form and a letter or document from the device sponsor that documents the following 10 items. a. The generic and trade name of the device b. The FDA HDE number (this is a six-digit number preceded by the letter H) c. The date of HUD designation d. Indications for use of the device e. A description of the device f. Contraindications, warnings, and precautions for use of the device g. Adverse effects of the device on health h. Alternative practices and procedures i. Marketing history j. 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