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Subject No. Page HUMANITARIAN DEVICE EXEMPTION (HDE) 219 1 of 5 Prepared By Prior Issue Date Institutional Review Board 1/16/2012 9/9/15 PURPOSE The purpose of this policy is to establish a procedure

How to fill out 219 humanitarian device exemption

1. Begin by gathering all the necessary information and documents required for the 219 humanitarian device exemption application. This may include details about the device itself, its intended use, supporting clinical data, and any applicable certifications or approvals.
2. Access the official website or portal where the application can be submitted. Ensure that you have a registered account or create one if necessary.
3. Start the application process by selecting the option for the 219 humanitarian device exemption. Follow the provided guidelines and instructions to navigate through the application form.
4. Enter the required information accurately and thoroughly. This may include details about the device manufacturer, device specifications, intended patient population, and any clinical evidence supporting its humanitarian use.
5. Provide any additional information or documentation as requested. This might include safety and efficacy data, clinical trial results, or any other relevant evidence to support the need for the device's availability under the humanitarian device exemption.
6. Review and double-check all the entered information to ensure accuracy and completeness. Make any necessary edits or amendments before moving forward.
7. Before submitting the application, ensure that you have completed all the mandatory fields and attached any required files or supporting documents. Verify that you have included your contact information for any further communication regarding the application.
8. Once you have reviewed and finalized the application, submit it through the designated submission button or process. Take note of any confirmation or reference number provided for future correspondence or tracking purposes.
9. After submitting the application, keep track of any updates or notifications provided by the regulatory authorities regarding the progress of your application.

Who needs 219 humanitarian device exemption?

1. Manufacturers: Manufacturers who are developing a medical device that is intended for humanitarian use and that meets the eligibility criteria outlined by the regulatory authorities may need to apply for the 219 humanitarian device exemption.
2. Patients: Patients who may benefit from accessing certain medical devices that are not yet approved or cleared by regulatory authorities but hold potential for significant health benefits might be in need of the 219 humanitarian device exemption.
3. Healthcare Providers: Healthcare providers who identify the need for a specific medical device in their patient population, which falls under the scope of the 219 humanitarian device exemption, may require this exemption to ensure timely access to the device for their patients.

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What is 219 humanitarian device exemption?

The 219 humanitarian device exemption allows for the use of certain medical devices that have not been approved by the FDA, in emergency situations.

Who is required to file 219 humanitarian device exemption?

Manufacturers or distributors of medical devices seeking to use the device in emergency situations are required to file the 219 humanitarian device exemption.

How to fill out 219 humanitarian device exemption?

To fill out a 219 humanitarian device exemption, the manufacturer or distributor must submit a written request to the FDA detailing the device, its intended use, and the emergency situation in which it will be used.

What is the purpose of 219 humanitarian device exemption?

The purpose of the 219 humanitarian device exemption is to expedite the availability of certain medical devices in emergency situations where FDA-approved devices are not readily available.

What information must be reported on 219 humanitarian device exemption?

The 219 humanitarian device exemption must include information about the device, its intended use, the emergency situation in which it will be used, and any known risks or benefits of the device.

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