Humanitarian Use Devices (HUDs) Exam
Questions and Answers 100% Pass
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. -
, [ANSWER]: Obtain informed consent from the patient and ensure that
reasonable patient protection measures are followed.
QUESTION: 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. -
[ANSWER]: The clinician obtains initial IRB approval and ensures
continuing review approval by the IRB.
Questions and Answers 100% Pass
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. -
, [ANSWER]: Obtain informed consent from the patient and ensure that
reasonable patient protection measures are followed.
QUESTION: 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. -
[ANSWER]: The clinician obtains initial IRB approval and ensures
continuing review approval by the IRB.
