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[PIPhysicianName] [TitleofHUDProposedUseofProtocol]Page1of9HumanitarianUseDevice ConsentandAuthorizationDocument DIRECTIONSFORUSEOFTHISTEMPLATE: Donotadjustthebottommarginorusethefooter. Donotdeletethewatermarkfieldsinthe footer.

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How to fill out humanitarian use device consent

01

Obtain the necessary forms from the appropriate regulatory body

02

Clearly explain the purpose of the humanitarian use device consent to the patient or their legal guardian

03

Ensure that the patient or legal guardian understands the risks and benefits of using the device

04

Have the patient or legal guardian sign the consent form

05

Keep a copy of the signed consent form in the patient's medical records

Who needs humanitarian use device consent?

01

Patients who are being offered a device that has not yet been approved by regulatory agencies for regular use

02

Patients who are in desperate need of treatment and have no other options available

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What is humanitarian use device consent?

Humanitarian use device consent is a regulatory submission that allows for the use of medical devices in humanitarian contexts.

Who is required to file humanitarian use device consent?

Manufacturers or sponsors of medical devices seeking to be used in humanitarian settings are required to file humanitarian use device consent.

How to fill out humanitarian use device consent?

To fill out humanitarian use device consent, manufacturers or sponsors need to provide detailed information about the medical device, its intended use in humanitarian settings, and any relevant safety and effectiveness data.

What is the purpose of humanitarian use device consent?

The purpose of humanitarian use device consent is to ensure that medical devices can be used in humanitarian settings where traditional regulatory requirements may not apply.

What information must be reported on humanitarian use device consent?

Information such as the device description, intended use, risks and benefits, safety and effectiveness data, and any relevant clinical trials must be reported on humanitarian use device consent.

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