Humanitarian Use Devices (HUDs)
questions and answers 2026\2027 A+
Grade
Although not required by regulation, which of the following actions does FDA guidance recommend for
clinical use of a HUD outside of its approved indication(s)?
Restrict use outside of approved indication(s) for situations that meet emergency use criteria.
Obtain informed consent from the patient and ensure that reasonable patient protection measures are
followed.
Request that the HDE holder submit an HDE supplement to obtain FDA approval of use outside of the
approved indication(s).
Limit use outside of approved indication(s) as these uses count towards the FDA-assigned number of
devices allowed to be shipped or sold in a year.
- correct answer Obtain informed consent from the patient and ensure that reasonable patient
protection measures are followed.
Which of the following statements is true regarding IRB approval of clinical use of a HUD in a healthcare
facility?
Since a HUD is a marketed device, the regulations do not require IRB approval for clinical use.
The clinician obtains initial IRB approval and ensures continuing review approval by the IRB.
After initial approval, the FDA allows an IRB to determine if it will require ongoing continuing review.
Since a HUD is a marketed device, the regulations prohibit an IRB from imposing restrictions on clinical
use of a HUD.
- correct answer The clinician obtains initial IRB approval and ensures continuing review approval by the
IRB.
questions and answers 2026\2027 A+
Grade
Although not required by regulation, which of the following actions does FDA guidance recommend for
clinical use of a HUD outside of its approved indication(s)?
Restrict use outside of approved indication(s) for situations that meet emergency use criteria.
Obtain informed consent from the patient and ensure that reasonable patient protection measures are
followed.
Request that the HDE holder submit an HDE supplement to obtain FDA approval of use outside of the
approved indication(s).
Limit use outside of approved indication(s) as these uses count towards the FDA-assigned number of
devices allowed to be shipped or sold in a year.
- correct answer Obtain informed consent from the patient and ensure that reasonable patient
protection measures are followed.
Which of the following statements is true regarding IRB approval of clinical use of a HUD in a healthcare
facility?
Since a HUD is a marketed device, the regulations do not require IRB approval for clinical use.
The clinician obtains initial IRB approval and ensures continuing review approval by the IRB.
After initial approval, the FDA allows an IRB to determine if it will require ongoing continuing review.
Since a HUD is a marketed device, the regulations prohibit an IRB from imposing restrictions on clinical
use of a HUD.
- correct answer The clinician obtains initial IRB approval and ensures continuing review approval by the
IRB.
