Humanitarian Device Exemption | FDA
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...
HDE Approvals - FDA
2024年2月7日 · On June 26, 1996, FDA issued a final rule to carry out provisions of the Safe Medical Devices Act of 1990 regarding humanitarian use devices (HUDs). This regulation became effective on October...
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...
Humanitarian Device Exemption (HDE) - Food and Drug Administration
2025年3月31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...
Federal Register :: Humanitarian Device Exemption Program; …
2019年9月6日 · This guidance answers common questions about the HDE program and responds to a requirement in the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) to define the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the FD&C Act (21 U.S.C. 360j(m)(2)(C)).
Understanding the Humanitarian Device Exemption Program
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.
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.
FDA Fact Sheet: Humanitarian Device Exemption (HDE)
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 designation request.
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
Humanitarian Device Exemption (HDE) Program | FDA
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...