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To obtain FDA certification, particularly for medical devices, you typically need to submit the following documents:

1. Device Description: Detailed information about the device, including its intended use, design, and specifications.

2. Labeling: Copies of labels, instructions for use, and any promotional materials.

3. Manufacturing Information: Details about the manufacturing process, facility, quality control procedures, and material sources.

4. Risk Analysis: A report identifying potential hazards and mitigation measures.

5. Clinical Data: Results from clinical trials or studies supporting the device's safety and effectiveness.

6. Preclinical Testing: Results from laboratory, bench, or animal studies.

7. Quality System Documentation: Compliance documentation with FDA’s Quality System Regulation (QSR), including SOPs and quality assurance practices.

8. Regulatory History: Information on any previous submissions or approvals for similar devices.

9. Substantial Equivalence Evidence: For 510(k) submissions, demonstrate that the device is substantially equivalent to a legally marketed device.

10. Pre-market Submission Forms: Completed forms specific to the type of submission, such as 510(k) or PMA.

These documents help the FDA evaluate the device’s safety, effectiveness, and compliance with regulatory standards.

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