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The IDE Application for an Investigational Device is a crucial form used for submitting investigations to the FDA regarding significant risk devices. This guide will provide you with clear, step-by-step instructions to effectively complete the application online.

Follow the steps to successfully complete your IDE application.

1. Use the ‘Get Form’ button to access the IDE Application. This will allow you to obtain the form and open it in your preferred document editor.
2. Fill in the application header with the required details. This typically includes the date of the application, device name, and the investigator's name.
3. Provide a comprehensive overview of the clinical plan in section 2. This should include a brief description of each clinical study being planned and its objectives.
4. Detail prior investigations in section 3. Include unpublished laboratory and clinical studies, along with any relevant publications discussing the safety and effectiveness of the devices.
5. In section 4, elaborate on the investigational plan, including the purpose, risks, monitoring procedures, and statistical considerations.
6. Complete the methods, facilities, and controls information in section 5. Ensure you describe how the device will be manufactured and processed.
7. Fill out the investigator agreements and financial interests in section 6. This includes a list of all investigators involved and their financial disclosures.
8. Gather IRB information in section 7, ensuring you include the names and contact information for each reviewing IRB.
9. Provide details about any other institutions involved in the investigation in section 8.
10. Specify device charges in section 9, ensuring to justify any associated costs.
11. Attach copies of labeling materials in section 10.
12. Collect all consent materials needed for subjects in section 11.
13. Provide any additional relevant information specified by the FDA in section 12.
14. List references and appendices according to the guidelines in sections 13 and 14.
15. Finally, review your filled-out application for completeness and accuracy before submission.

Initiate your application process now by accessing the IDE Application online.