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The tests required for FDA certification in the United States depend on the type of medical device being submitted for approval. However, in general, the following types of tests may be required:

1. Biocompatibility Testing: This is to assess the safety of materials that come into contact with the human body. This is especially critical for devices that are implanted or come into contact with tissue.

2. Performance Testing: Devices must demonstrate that they perform as intended. This includes functionality tests, stress testing, and other tests that show the device works safely and effectively.

3. Electrical Safety and Electromagnetic Compatibility (EMC) Testing: For devices with electrical components (e.g., pacemakers, diagnostic equipment), testing ensures that they meet safety standards for electrical hazards and do not interfere with other electronic devices.

4. Sterility and Microbial Testing: If the device is intended to be sterile, it will need to undergo sterility assurance testing and microbial testing to verify that it is free from harmful pathogens.

5. Shelf Life and Stability Testing: Some devices require tests to determine how long they maintain their functionality and safety over time, especially if the device is subject to degradation or expiration (e.g., drugs, biologics, or certain medical devices).

6. Clinical Testing: Depending on the device's risk profile, clinical trials or studies may be necessary to provide data on its safety and effectiveness in human use. This is typically required for higher-risk devices (Class III).

7. Labeling and Packaging Testing: Devices must be tested for proper labeling, including instructions for use, warnings, and other required information. Packaging must ensure the integrity and safety of the device during storage and transportation.

8. Radiation Testing: If the device emits radiation (e.g., X-ray machines), it must be tested to ensure it complies with FDA radiation safety standards.

9. Mechanical Testing: For devices like prosthetics, joint implants, and orthopedic devices, mechanical testing may be required to assess strength, durability, and performance under stress.

Each device type may have additional or specific testing requirements, so it's important to consult the FDA's guidance documents for the relevant device classification (Class I, II, or III) and regulations.

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