Although not required by regulation, which of the following actions does FDA guidance recommend for clinical use of a HUD outside of its approved
... [Show More] 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.
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.
The clinician obtains initial IRB approval and ensures continuing review approval by the IRB.
All of the following regulatory requirements apply to an investigation of a HUD consistent with the HDE approved indication(s), EXCEPT:
Human subject protection requirements.
Financial disclosure requirements.
HIPAA authorization requirements.
Investigational Device Exemption requirements.
Investigational Device Exemption requirements.
An investigation to collect data on a new indication of a significant risk HUD requires:
IRB approval and a revised Humanitarian Use Device (HUD) designation.
IRB approval and an Investigational Device Exemption (IDE).
IRB approval without an Investigational Device Exemption (IDE).
IRB approval and a revised Humanitarian Device Exemption (HDE).
IRB approval and an Investigational Device Exemption (IDE).
FDA approval of a Humanitarian Device Exemption (HDE) is based on all of the following criteria EXCEPT:
Probable benefit to health outweighs the risk.
Assurance of safety and effectiveness.
No comparable marketed device is available to treat or diagnose the disease or condition.
The manufacturer could not otherwise bring the device to market.
Assurance of safety and effectiveness.
A clinician may use a HUD without IRB approval:
In a clinical investigation to collect data on an HDE approved indication.
For compassionate use where no alternative device is available for a patient's condition.
If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient.
For clinical use only.
If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient.
The two-step process of obtaining an FDA marketing approval for a HUD includes:
Submitting a pre-market approval (PMA) to FDA then obtaining a HUD designation.
Obtaining a HUD designation then submitting HUD use to an IRB.
Obtaining a HUD designation then submitting a pre-market approval (PMA) to the FDA.
Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA.
Obtaining a HUD designation then submitting a Humanitarian Device Exemption (HDE) to the FDA.
A Humanitarian Use Device (HUD) is a medical device:
Used to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the U.S. annually. [Show Less]