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Humanitarian Use Device Application For Community Medical Centers Institutional Review Board Review HDE #:Name of Device HUD Manufacturer:Type of Funding: Pharmaceutical Co. Foundation State or Federal

How to fill out humanitarian use device application

How to fill out humanitarian use device application

1. Step 1: Gather all necessary information and documentation. This may include medical device description, intended use, clinical trial data, risk analysis, etc.
2. Step 2: Complete and submit Form FDA 3881, which is the formal request for FDA review of the humanitarian use device application.
3. Step 3: Prepare a detailed summary of safety and effectiveness data to support the humanitarian use device application.
4. Step 4: Include a proposed labeling for the device, which should clearly outline the indications, contraindications, warnings, and precautions for use.
5. Step 5: Provide any additional supporting documentation, such as clinical studies or published literature, to further demonstrate the device's safety and effectiveness.
6. Step 6: Pay the required user fee for the application.
7. Step 7: Submit the complete application package to the FDA for review.
8. Step 8: Monitor the status of the application and respond to any requests for additional information or clarification from the FDA.
9. Step 9: Once the application is approved, comply with any post-approval requirements or conditions set by the FDA.
10. Step 10: Maintain proper documentation and records of the entire application process for future reference and compliance purposes.

Who needs humanitarian use device application?

1. Medical device manufacturers or developers who wish to market a device for a rare disease or condition that affects fewer than 4,000 individuals in the United States per year.
2. Patients who suffer from rare diseases or conditions and could potentially benefit from the use of a medical device that has not yet been approved for general use by the FDA.

What is Humanitarian Use Device Application For Community Medical Centers Institutional Review Board Review Form?

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