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...
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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...
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...
Humanitarian Device Exemption (HDE) - Food and Drug Administration
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...
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First surgical device of its kind granted key FDA exemption
2024年12月9日 · Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey …
Humanitarian device exemption - Novitas Solutions
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 …
Listing of CDRH Humanitarian Device Exemptions | FDA
2024年5月29日 · Search the listing of Humanitarian Device Exemptions (HDEs) for 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 designation request.