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Getting a Humanitarian Use Device to Market | FDA Getting a Humanitarian Use Device (HUD) to market is a two-step process The applicant must first obtain an HUD designation from the FDA's Office of Orphan Products Development (OOPD) and then
Humanitarian Device Exemption (HDE): 2025 FDA Guide Learn FDA's Humanitarian Device Exemption (HDE) pathway for rare disease devices affecting ≤8,000 patients Complete guide to HUD designation, profit restrictions IRB requirements
HDE At-a-Glance_DiMe_RegPath Humanitarian Device Exemption (HDE) is a FDA regulatory pathway for certain digital health products that are intended to benefit patients by treating or diagnosing a disease or condition that a ects or is manifested in fewer than 8,000 individuals in the United States per year - the FDA’s definition of a “rare” disease
Humanitarian Use Device | Human Research Protection Program (HRPP) An HDE is a type of Pre-Market Approval (PMA) that allows the FDA to grant an exemption from the effectiveness requirements of the PMA regulations Devices approved with an HDE are referred to as a Humanitarian Use Devices (HUD)
FDA Fact Sheets: Humanitarian Device Exemption (HDE) Humanitarian Device Exemption (HDE) application is submitted to FDA to obtain approval for an HUD and takes part in a two-step process First, the company is required to file a humanitarian use device designation request
Humanitarian Device Exemption | FDA The Humanitarian Device Exemption Program provides a regulatory pathway for medical devices intended for diseases or conditions that affect small populations
Humanitarian device exemption (HDE) | Definitive Healthcare An HDE is an application submitted to the Food and Drug Administration (FDA) to obtain approval for a Humanitarian Use Device (HUD) A HUD is a device that intends to benefit patients by diagnosing or treating a disease or condition that manifests or affects fewer than 8,000 individuals in the U S each year
Humanitarian Device Exemption Definition Origin: HDE is a regulatory pathway established by the FDA under 21 CFR 814 Subpart H and Section 520(m) of the FD C Act for devices treating ≤8,000 individuals annually
Syllabus: HDE 100C 001 SQ 2024 To take this course, students must have completed PSC 001 or PSC 001Y The syllabus, schedule, reading material, gradebook, and assignment information are available on Canvas Live chat and phone support for Canvas is available 24 hours a day, 7 days a week for students
Humanitarian Device Exemption (HDE) Postmarket Activities After HDE approval, the HDE holder is responsible for ensuring that a humanitarian use device (HUD) is administered only in facilities having IRB oversight in accordance with the Agency's