Jan 13, 2025 · Humanitarian Device Exemption (HDE): a marketing application for an HUD (Section 520 (m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the …

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 …

Jul 1, 2025 · What Is a Humanitarian Device Exemption (HDE)? An HDE is FDA's marketing approval for Humanitarian Use Devices (HUDs)—medical devices intended to treat or diagnose diseases …

A 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 …

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.

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...

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 …

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 …

4 days ago · Humanitarian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

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 …