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 …

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 …

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 …

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 …

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 …

Generally, these are known as orphan devices. The FDA calls such a device approved in this manner a "Humanitarian Use Device" (HUD).

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.

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 …

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 …

device exemption (HDE) application is submitted to FDA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrat.