HUD Exam Questions with Complete
Solutions2
What is a HUD? - ANSWERS-Humanitarian Use Device - a medical device intended to benefit
patients in the treatment or diagnosis of a disease or condition that affects or is manifested in
not more than 8,000 individuals in the US per year.
What are the responsibilities of an HDE holder? - ANSWERS-1) Ensuring that a HUD is
administered only in facilities that have oversight by an IRB, including CR.
2) Ensuring a HUD is only administered if such use has been approved by an IRB (IRB approval is
not needed for each individual use, but they may choose to limit use based on certain factors)
What must an IRB do for a HUD? - ANSWERS-Perform the initial review of a protocol using an
HUD and apply the same approval criteria as it does for any other FDA regulated product, even
though use of the HUD under the HDE is not considered research.
What is the purpose of an HDE? - ANSWERS-A Humanitarian Device Exemption provides a
pathway for manufactures to develop devices that will benefit small patient populations.
Whats the purpose of the HUD program? - ANSWERS-Provides a route for marketing devices
that would benefit patients with rare conditions or diseases.
What is an HDE? - ANSWERS-It is a marketing application for an HUD. An HDE is exempt from
the effectiveness requirements of the FDCA when used in accordance with FDA approved
indications, and is subject to certain profit and use restrictions.
What is unique about a HUD? - ANSWERS-A HUD is a legally marketed device, and its use within
its approved indication does not constitute a clinical investigation, but IRB approval is required
before a HUD can be used at a facility for clinical care.
Solutions2
What is a HUD? - ANSWERS-Humanitarian Use Device - a medical device intended to benefit
patients in the treatment or diagnosis of a disease or condition that affects or is manifested in
not more than 8,000 individuals in the US per year.
What are the responsibilities of an HDE holder? - ANSWERS-1) Ensuring that a HUD is
administered only in facilities that have oversight by an IRB, including CR.
2) Ensuring a HUD is only administered if such use has been approved by an IRB (IRB approval is
not needed for each individual use, but they may choose to limit use based on certain factors)
What must an IRB do for a HUD? - ANSWERS-Perform the initial review of a protocol using an
HUD and apply the same approval criteria as it does for any other FDA regulated product, even
though use of the HUD under the HDE is not considered research.
What is the purpose of an HDE? - ANSWERS-A Humanitarian Device Exemption provides a
pathway for manufactures to develop devices that will benefit small patient populations.
Whats the purpose of the HUD program? - ANSWERS-Provides a route for marketing devices
that would benefit patients with rare conditions or diseases.
What is an HDE? - ANSWERS-It is a marketing application for an HUD. An HDE is exempt from
the effectiveness requirements of the FDCA when used in accordance with FDA approved
indications, and is subject to certain profit and use restrictions.
What is unique about a HUD? - ANSWERS-A HUD is a legally marketed device, and its use within
its approved indication does not constitute a clinical investigation, but IRB approval is required
before a HUD can be used at a facility for clinical care.
