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Click ‘Get Form’ to open the Humanitarian Device Exemption (HDE) Program application in the editor.
Begin by filling out the Applicant Information section. Provide your organization’s name, primary contact details, and mailing address.
In the Project Information section, specify your project title, funding amount requested, and any matching funding if applicable.
Detail the planting schedule by entering specific dates and times for both the planting and makeup dates. Ensure these fall within the approved timeframe.
Complete the Project Narrative and Ongoing Care section with a detailed summary of your project, including timelines, roles of youth, and maintenance plans for at least two years post-planting.
Check off all required supplemental materials included with your application to ensure completeness before submission.
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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.
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People also ask
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.
Related links
Humanitarian Device Exemption (HDE) Program
Oct 21, 2019 Humanitarian Use Device (HUD): A medical device intended to benefit patients in the treatment or diagnosis of diseases or conditions.
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
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