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This document outlines the regulations, responsibilities, and guidance related to Humanitarian Use Devices (HUDs) and Humanitarian Device Exemptions (HDEs), including their approval processes and

How to fill out humanitarian use device exemption

How to fill out Humanitarian Use Device Exemption

1. Identify the device you want to exempt and confirm it qualifies as a Humanitarian Use Device (HUD).
2. Gather supporting documentation, including a detailed description of the device and its intended use.
3. Provide evidence supporting the prevalence of the condition the device is intended to treat, as it must affect fewer than 8,000 individuals in the U.S. annually.
4. Prepare a comprehensive application to the FDA, including the device's design, specifications, and manufacturing processes.
5. Include information on clinical data supporting the device's safety and effectiveness.
6. Submit the application and pay any required fees.
7. Respond to any requests for additional information from the FDA during their review process.
8. Await FDA decision on the application for the Humanitarian Use Device Exemption.

Who needs Humanitarian Use Device Exemption?

1. Medical device manufacturers seeking to market devices intended for use in small patient populations with rare diseases.
2. Healthcare providers looking to access innovative treatments for patients with conditions affecting fewer than 8,000 individuals annually.
3. Patients suffering from rare diseases who may benefit from devices that are not commercially viable due to their low prevalence.

People Also Ask about

What is a humanitarian use device?

A Humanitarian Use Device ( HUD ) is defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Orphan Diseases).

What are the requirements for humanitarian device exemption?

The provisions for obtaining an HDE are: The device is designed to treat or diagnose a disease or condition that affects fewer than 8,000 individuals per year in the U.S. The device is not available otherwise, and there is no comparable device available to treat or diagnose the disease or condition; and.

What is a device exemption?

An Investigational Device Exemption (IDE) is a regulatory submission that permits an investigational device to be used in a clinical study in order to collect safety and effectiveness data.

What is the FDA humanitarian device exemption?

Humanitarian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

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?

Allows the Secretary to grant an exemption from certain effectiveness requirements for a device for which the Secretary finds that: (1) it is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals; (2) the device would not be available without the exemption and no comparable

What is a humanitarian exemption?

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 requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.

For pdfFiller’s FAQs

What is Humanitarian Use Device Exemption?

The Humanitarian Use Device Exemption (HUD) is a regulatory pathway in the United States that allows for the approval of medical devices intended to treat or diagnose a disease or condition that affects a small number of patients, thus allowing the device to be used without having to undergo the same extensive testing required for larger market devices.

Who is required to file Humanitarian Use Device Exemption?

The manufacturer of the medical device is required to file for a Humanitarian Use Device Exemption with the FDA to obtain approval for their device designed for a rare condition.

How to fill out Humanitarian Use Device Exemption?

To fill out a Humanitarian Use Device Exemption, the manufacturer must provide specific documentation, including a description of the device, its intended use, and the rationale for its humanitarian use designation. They must also submit data regarding the safety and effectiveness of the device based on its intended use, along with any relevant clinical data.

What is the purpose of Humanitarian Use Device Exemption?

The purpose of the Humanitarian Use Device Exemption is to facilitate the development, approval, and availability of medical devices that are necessary for the treatment of rare diseases affecting fewer than 8,000 patients annually in the United States.

What information must be reported on Humanitarian Use Device Exemption?

Information that must be reported includes the device description, intended use, clinical data supporting safety and effectiveness, information about any previous similar devices, and a summary justifying the humanitarian use designation, alongside any additional information requested by the FDA.