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INSTITUTIONAL REVIEW BOARD Application for Humanitarian Use Device Under a Humanitarian Device Exemptions for newly proposed use of Humanitarian Use Device Please refer to the IRB Policy Humanitarian

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What is under a humanitarian device?

A humanitarian device refers to a regulatory framework that allows for the development and use of medical devices intended to benefit patients with rare diseases or conditions.

Who is required to file under a humanitarian device?

Manufacturers of medical devices intended for use in humanitarian programs must file under a humanitarian device exemption (HDE).

How to fill out under a humanitarian device?

Filling out under a humanitarian device involves completing the required application forms, providing detailed information about the device, its intended use, and clinical data that supports the application.

What is the purpose of under a humanitarian device?

The purpose is to facilitate the growth and availability of devices that address unmet medical needs for patients with rare diseases, offering them treatment options that would otherwise not be feasible.

What information must be reported on under a humanitarian device?

Information that needs to be reported includes device description, indications for use, safety and effectiveness data, labeling, and any potential risks associated with the device.

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