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Humanitarian Device Exemption (HDE) Program

Humanitarian Device Exemption (HDE) Program 2025

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The 'Trees for Kids' document outlines the application process, eligibility criteria, funding restrictions, and educational requirements for a program aimed at planting trees with youth involvement. It specifies that applications must be submitted electronically by March 3, 2023, and grants of up to $2,500 are available for local governments and eligible organizations. The document emphasizes the importance of species diversity, proper planting techniques, ongoing care for the trees, and includes detailed instructions on project planning and reimbursement procedures.

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What is the difference between a 510k and a HDE?

Unlike the 510k process, HDE approval is device approval rather than clearance for marketing and distribution. If another equivalent (an actual term used is comparable) device is already being legally marketed, then the FDA may not approve an HDE application.

What is the purpose of the medical device Act?

The SMDAs primary goals are to: Ensure medical devices placed on the market are safe and effective. Accelerate reporting of adverse events to the U.S. Food and Drug Administration (FDA) Remove defective products from the marketplace.

What does the Safe medical device Act of 1990 require?

The SMDA requires user facilities to report: device-related deaths to the FDA and the device manufacturer; device-related serious injuries to the manufacturer, or to FDA if the manufacturer is not known; and. submit to FDA on an annual basis a summary of all reports submitted during that period.

What is the humanitarian device exemption?

Humanitarian Device Exemption (HDE): a marketing application for an HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FDC Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FDC Act and is subject to certain profit and use restrictions.

What criteria qualifies a device for an IDE exemption?

Exempted Investigations for Diagnostic Devices The device: Is noninvasive: A noninvasive device is one that does not, by design or intention: or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra; or.

What is the 1990 the Humanitarian Device Exemption Safe Medical Devices Act?

A Humanitarian Device Exemption (HDE) is a type of Premarket Application described under the Safe Medical Devices Act (SMDA) of 1990 and allows the FDA to grant an exemption from the effectiveness requirements of the Premarket Approval (PMA) regulations.

What is a humanitarian medical device?

Humanitarian Use Devices (HUD) are medical devices developed to address challenges faced by a very small number of patients, and for which no expectation of recovering development/manufacturing costs can be considered if a traditional market size risk/benefit analysis is required.

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Humanitarian Device Exemption (HDE) Program 2025

Here's how it works

The best way to modify Humanitarian Device Exemption (HDE) Program online

See more Humanitarian Device Exemption (HDE) Program versions

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Got questions?

What is the difference between a 510k and a HDE?

What is the purpose of the medical device Act?

What does the Safe medical device Act of 1990 require?

What is the humanitarian device exemption?

What criteria qualifies a device for an IDE exemption?

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