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Contains Nonbinding RecommendationsHumanitarian Device Exemption (HDE) Program Guidance for Industry and Food and Drug Administration Staff Document issued on September 6, 2019. The draft of this

How to fill out humanitarian device exemption hde

How to fill out humanitarian device exemption hde

1. To fill out a Humanitarian Device Exemption (HDE), you can follow these steps:
2. Obtain the HDE application form from the relevant regulatory authority.
3. Provide accurate information about the device and its intended use.
4. Submit comprehensive scientific and clinical data to support the safety and effectiveness of the device.
5. Include information on any alternatives available for treating the same condition.
6. Provide details on the number of patients that would be affected by the device's availability.
7. Submit any additional supporting documentation required by the regulatory authority.
8. Pay any associated fees and submit the completed application.
9. Wait for the regulatory authority to review and evaluate the HDE application.
10. Cooperate with the regulatory authority during the review, providing any requested additional information or clarification.
11. If approved, ensure compliance with all post-market requirements and obligations set by the regulatory authority.

Who needs humanitarian device exemption hde?

1. Humanitarian Device Exemption (HDE) is needed for medical device manufacturers who wish to market a device intended for use in the treatment or diagnosis of a rare disease or condition affecting fewer than 4,000 individuals in the United States per year.
2. In order to qualify for an HDE, the device must be intended to benefit patients by treating or diagnosing conditions that do not have other adequate treatment options available.
3. Examples of individuals who may need an HDE include patients with rare genetic disorders, certain types of cancers, or other conditions for which there are limited treatment options.

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What is humanitarian device exemption hde?

HDE is a regulatory pathway for medical devices intended to benefit patients by treating or diagnosing diseases or conditions that affect fewer than 8,000 individuals in the United States.

Who is required to file humanitarian device exemption hde?

Manufacturers or sponsors of medical devices seeking HDE approval from the FDA are required to file for humanitarian device exemption.

How to fill out humanitarian device exemption hde?

To fill out HDE application, manufacturers need to provide information on device description, intended use, patient population, risks and benefits, and any available clinical data.

What is the purpose of humanitarian device exemption hde?

The purpose of HDE is to encourage the development of medical devices for rare diseases or conditions that might not otherwise be commercially viable.

What information must be reported on humanitarian device exemption hde?

Information on device description, intended use, patient population, risks and benefits, as well as any available clinical data must be reported on HDE application.