A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
You can request a Humanitarian Device Exemption (HDE) from the FDA. It is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug and Cosmetic Act.
If a physician in an emergency situation determines that IRB approval for the use of the HUD at the facility cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be used without prior IRB approval.
The physician must, within five (5) days after the emergency use of the device, provide written notification of the use to the IRB chairperson.
In order to obtain HUD designation, you must provide documentation, with appended authoritative references, to demonstrate that the device meets the definition of 21 CFR 814.3(n). In addition to describing the disease or condition, you also must provide the proposed indications for use of the device and the reasons why such a device is needed for the patient population.
If the HUD application is designated, then you can submit the HDE marketing application to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) for marketing review.
A HDE application does not need to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.
However, the application 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. You must take into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, you must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that you could not otherwise bring the device to market.
Due to the amount and complexity of the data required for a HUD application, it can take several weeks to complete the submission. Therefore, we recommend you begin working on the submission as early as possible.
To provide a more expeditious review of a HUD designation request, the FDA Office of Orphan Products Development (OOPD) suggests the following be provided as part of the request.
When adequate studies or literature citations do not exist, OOPD will accept written statements from three independent experts in the field if they contain adequate justification for the population estimates.