Humanitarian Use Devices (HUDs) Questions and Answers Latest Version (2024/2025) Already Passed

Humanitarian Use Devices (HUDs) Questions and Answers Latest Version (2024/2025) Already Passed What is a Humanitarian Use Device (HUD)? A) A medical device intended for general use B) A device designed for a condition affecting no more than 8,000 people per year in the U.S. C) A device used exclusively in humanitarian aid missions D) A device that does not require FDA approval Who grants approval for HUD designation? A) World Health Organization (WHO) B) Centers for Disease Control and Prevention (CDC) C) U.S. Food and Drug Administration (FDA) D) American Medical Association (AMA) What is the primary purpose of an HUD? A) To treat common diseases 2 B) To be used in emergency situations only C) To provide treatment for rare conditions with no alternative therapies D) To replace existing medical devices in hospitals Which requirement must be met for a device to qualify as an HUD? A) It must be available over-the-counter B) It must be intended for use in fewer than 8,000 patients per year in the U.S. C) It must be manufactured by a nonprofit organization D) It must be distributed internationally What is a Humanitarian Device Exemption (HDE)? A) A program that waives all regulatory requirements for HUDs B) A regulatory pathway allowing HUDs to be marketed without proof of effectiveness C) A temporary approval for devices during public health emergencies D) A license to sell HUDs internationally Who can approve the use of an HUD in a healthcare facility? A) Any licensed physician without restrictions 3 B) An Institutional Review Board (IRB) C) The device manufacturer D) The U.S. Department of Health and Human Services What is a key limitation of HUDs under an HDE? A) They cannot be used outside of clinical trials B) They cannot be sold for profit in most cases C) They are only available in government