2025年1月13日 · 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 effectiveness...

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...

2024年5月29日 · Search the listing of Humanitarian Device Exemptions (HDEs) for medical devices.

2025年3月17日 · Humanitarian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III...

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.

An HDE must contain sufficient information for the Food and Drug Administration (FDA) to determine that the probable benefit to health outweighs the risk of injury or illnesses, taking into account the probable risks and benefits of currently available devices or …

2024年9月29日 · The Humanitarian Device Exemption (HDE) program offers an expedited regulatory pathway for medical devices aimed at treating or diagnosing rare diseases or conditions, which affect fewer than 8,000 individuals in the United States annually.

2024年8月12日 · The humanitarian device exemption (HDE) is the application process. An HDE is similar in both form and content to a pre-market approval (PMA) application; however, the HDE is “exempt” from the effectiveness requirements of a PMA.

2019年9月5日 · This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions on HDE applications, post-approval requirements, and special...

2016年2月25日 · FDA guidance on the HDE process provides that a product may be designated a humanitarian use device (HUD) eligible for HDE approval if it is 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.” While an HDE ...