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About Humanitarian Use
Medical Devices
(HUDs)
On June 26, 1996, FDA issued a final
rule to carry out provisions of the Safe Medical Devices Act of
1990 regarding humanitarian use devices (HUDs). An HUD is a device
that is intended to benefit patients by treating or diagnosing a
disease or condition that affects fewer than 4,000 individuals in
the United States per year. A device manufacturer’s research and
development costs could exceed its market returns for diseases or
conditions affecting small patient populations. FDA, therefore,
developed and published this regulation to provide an incentive
for the development of devices for use in the treatment or
diagnosis of diseases affecting these populations.
An Humanitarian Device Exemption (HDE)
application is not required to contain the results of
scientifically valid clinical investigations demonstrating that
the device is effective for its intended purpose. The application,
however, must contain sufficient information for FDA to determine
that the device does not pose an unreasonable or significant risk
of illness or injury, and that 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. Additionally, the
applicant must demonstrate that no comparable devices are
available to treat or diagnose the disease or condition, and that
they could not otherwise bring the device to market.
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