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发帖数: 1652 | 1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H
An Humanitarian Use Device (HUD) is a device that is intended to benefit
patients by treating or diagnosing a disease or condition that affects or is
manifested in 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. The HUD provision of the regulation provides an incentive for
the development of devices for use in the treatment or diagnosis of diseases
affecting these populations.
To obtain approval for an HUD, an humanitarian device exemption (HDE)
application is submitted to FDA. An HDE is similar in both form and content
to a premarket approval (PMA) application, but is exempt from the
effectiveness requirements of a PMA. An 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.
An approved HDE authorizes marketing of the HUD. However, an HUD may only be
used in facilities that have established a local institutional review board
(IRB) to supervise clinical testing of devices and after an IRB has
approved the use of the device to treat or diagnose the specific disease.
The labeling for an HUD must state that the device is an humanitarian use
device and that, although the device is authorized by Federal Law, the
effectiveness of the device for the specific indication has not been
demonstrated. |
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