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Humanitarian Device Exemption
A Humanitarian Use Device (HUD) is a device that has been given special
approval by the FDA under the Humanitarian Device Exemption (HDE) regulations.
The "normal" approval process for devices requires that companies
demonstrate that the devices are safe and effective (better than medicine or
another procedure). However, the FDA recognizes that sometimes a condition is so
unusual that it would be difficult for a company to scientifically demonstrate
effectiveness of their device in the large number of patients that usually must
be tested. In these special situations, they may grant a HDE provided that:
1) the device does not pose an unreasonable or significant risk of illness or
injury and,
2) the probable benefit to health outweighs the risk of injury or illness
from its use, taking into account the probable risks and benefits of currently
available devices or alternative forms of treatment.
A Humanitarian Use Device may only be used in facilities that have an
Institutional Review Board (IRB)* to supervise clinical testing of devices and
after the IRB has approved the use of the device to treat or diagnose the
specific disease.
Have questions?
If you have any questions regarding HUDs or the HDE regulations, please
contact:
Kim Brown, RN
216/444-5380
brownk@ccf.org
The Cleveland Clinic IRB
216/444-2924
* The Institutional Review Board (IRB) is
an administrative body established under federal regulations whose
mission is to adequately protect the rights, safety and welfare of
research participants and to uphold the ethical principles for human
subject protections. The mission of members who sit on IRBs is to
determine that risks to subjects are minimized and are justified in
relation to anticipated benefits, if any, and the importance of the
knowledge that may be expected to result. The IRB assesses the purpose
of the research to verify that informed consent will be voluntarily
obtained and appropriately documented. The IRB assures the research plan
includes adequate provisions for monitoring the data collected to ensure
the safety of subjects and that subject privacy and confidentiality of
data are protected. In carrying out it’s obligations, the IRB may
approve, require modification to, or disapprove research applications
and may suspend or terminate it’s approval of ongoing research that is
non-compliant with these regulations.
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