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Institutional Review Board Human Research Protection Program 1 Park Avenue 6th Floor New York, NY 10016 http://irb.med.nyu.edu Humanitarian Use Device (HUD) CONSENT FORMPhysician Name: Dept: Phone:
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How to fill out humanitarian use device hud

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How to fill out humanitarian use device hud

01
Step 1: Gather all necessary information and documents required for the HUD application.
02
Step 2: Complete the FDA's Form 3881 for the humanitarian use device (HUD). Provide accurate and detailed information about the device, its intended use, and the patient population it will benefit.
03
Step 3: Include any supporting data or clinical evidence that demonstrates the safety and effectiveness of the HUD.
04
Step 4: Submit the completed Form 3881 along with all necessary documents to the FDA for review. Make sure to follow the submission guidelines provided by the FDA.
05
Step 5: Await feedback from the FDA, which may include requests for additional information or clarification.
06
Step 6: Address any FDA requests promptly and provide the requested information within the specified timeframe.
07
Step 7: If the HUD application is approved by the FDA, follow any additional requirements or conditions specified by the FDA for marketing and distribution of the HUD.

Who needs humanitarian use device hud?

01
Companies or individuals developing medical devices that are intended to treat or diagnose a disease or condition affecting less than 4,000 individuals in the United States per year.
02
Patients who suffer from rare diseases or conditions and could potentially benefit from innovative medical devices that have not yet received full FDA approval.
03
Healthcare professionals seeking access to medical devices that have shown promising results in early-stage clinical trials, but have not completed the full FDA approval process.

What is Humanitarian Use Device (HUD) CONSENT - med nyu Form?

The Humanitarian Use Device (HUD) CONSENT - med nyu is a Word document that can be completed and signed for specified purposes. Then, it is provided to the relevant addressee to provide certain details and data. The completion and signing can be done manually or via a suitable service like PDFfiller. These services help to send in any PDF or Word file without printing them out. It also allows you to edit it for your requirements and put legit digital signature. Once you're good, the user ought to send the Humanitarian Use Device (HUD) CONSENT - med nyu to the recipient or several ones by mail and even fax. PDFfiller is known for a feature and options that make your Word form printable. It includes different options when printing out. No matter, how you'll send a form after filling it out - physically or electronically - it will always look professional and clear. In order not to create a new writable document from the beginning over and over, turn the original file into a template. After that, you will have a rewritable sample.

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Humanitarian Use Device (HUD) is a designation by the FDA for medical devices intended to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year.
Manufacturers of medical devices seeking the HUD designation are required to file for it with the FDA.
To fill out the HUD application, manufacturers must provide information on the device, the disease or condition it is intended to treat, and clinical data supporting its safety and efficacy.
The purpose of HUD is to incentivize the development of medical devices for rare diseases or conditions by providing a streamlined regulatory pathway to market.
Information on the device, the disease or condition it is intended to treat, clinical data, and patient utilization data must be reported on the HUD application.
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