Frequently Asked Questions (FAQS)
What is a Humanitarian Use Device (HUD)?
As defined in 21 CFR 814.3(n), a 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.”
When does FDA make the determination that the disease or condition affects or is manifested in fewer than 4,000 individuals in the United States per year?
FDA makes its determination when you a request a HUD designation. You should submit your request for a HUD designation before submitting an application for a HDE. You should include FDA’s HUD designation letter in your application.
What is a medically plausible subset?
If the disease or conditions occurs in >4,000 patients/year, the device could be used in a subset of the disease or condition as long as the sponsor shows the subset is medically plausible (NOT just "readily identifiable“). A medically plausible subset is one in which use of the device is limited to that subset because of some inherent property of the device and/or the disease. That is, the sponsor must explain why the device couldn't also be used in all patients with disease or condition.