Get the free Humanitarian Use Device Consent for Treatment Only template

IRB# Approved: OREGON HEALTH & SCIENCE UNIVERSITY Humanitarian Use Device Consent Form for Treatment Entitle: HDE# Give number assigned by FDA : Give name of device PHYSICIAN:Name, Degrees (503)494XXXXTREATMENT

How to fill out humanitarian use device consent

How to fill out humanitarian use device consent

1. To fill out a humanitarian use device consent form, follow these steps:
2. Begin by reading the entire consent form carefully, paying attention to any special instructions or required documents.
3. Fill in your personal information accurately, such as your name, address, contact numbers, and email address.
4. If applicable, provide information about your medical condition or the condition of the person for whom the device is intended.
5. Review the risks and benefits section of the form thoroughly, ensuring you understand the potential risks and benefits associated with the device.
6. Consult with your healthcare provider or the device manufacturer if you have any questions or concerns about the information provided in the form.
7. Sign and date the consent form to indicate your understanding and willingness to participate in the use of the humanitarian device.
8. Make a copy of the completed form for your records and submit the original to the appropriate authority or institution as instructed in the form.

Who needs humanitarian use device consent?

1. The individuals or entities who need humanitarian use device consent include:
2. - Patients who are willing to use a medical device that has not yet been approved by the regulatory authorities but is granted humanitarian use authorization.
3. - Physicians or healthcare providers who plan to use a humanitarian use device for the treatment of their patients.
4. - Medical researchers who are conducting clinical trials or studies involving the use of humanitarian use devices.
5. - Institutions or organizations involved in the distribution, maintenance, or monitoring of humanitarian use devices.

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What is humanitarian use device consent?

Humanitarian use device consent is a process where manufacturers seek permission to use their medical devices in emergency situations or other critical medical needs.

Who is required to file humanitarian use device consent?

Manufacturers of medical devices are required to file humanitarian use device consent.

How to fill out humanitarian use device consent?

To fill out humanitarian use device consent, manufacturers must provide necessary information about the device, intended use, and justification for emergency use.

What is the purpose of humanitarian use device consent?

The purpose of humanitarian use device consent is to allow expedited access to critical medical devices in emergency situations where traditional approval processes would delay availability.

What information must be reported on humanitarian use device consent?

Information such as device specifications, intended use, emergency situation description, and risk management strategies must be reported on humanitarian use device consent.