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Special 510(k): Device Modification to ABL9O FlexRADIOMETERKNr7 Section 5. 510(k) Summary 1920111. Administrative Device Information Device Name: Common Name: Product Code: Registration Number: Classification: Classification

How to fill out special 510k device modification

How to fill out special 510k device modification

1. To fill out a special 510k device modification, follow these steps:
2. Start by downloading the special 510k device modification template from the official FDA website.
3. Fill in your company's information, including name, address, and contact details.
4. Provide the details of the original device that is being modified, including its name, model number, and the 510k number it was initially cleared under.
5. Clearly describe the modifications being made to the device. Include all relevant information such as changes in design, materials, performance, or labeling.
6. If applicable, include any clinical trial data or results that support the safety and effectiveness of the modified device.
7. Summarize the risk analysis and mitigation measures taken to ensure the safety and performance of the modified device.
8. Include any additional information or documentation that is necessary to support the modification.
9. Sign and date the special 510k device modification document.
10. Submit the completed form along with any required supporting documents to the FDA for review and clearance.

Who needs special 510k device modification?

1. Special 510k device modification is needed by medical device manufacturers who intend to make significant modifications to an existing FDA cleared device.
2. These modifications may include changes in design, materials, performance, or labeling that could significantly affect the safety or effectiveness of the device.
3. Before introducing the modified device into the market, the manufacturer must obtain clearance from the FDA through the special 510k device modification process.
4. Failure to obtain the required clearance may result in regulatory non-compliance and can have serious consequences for the manufacturer.

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What is special 510k device modification?

The special 510(k) device modification is a submission made to the FDA for modifications to an existing device that does not require a new premarket notification (510(k)).

Who is required to file special 510k device modification?

Manufacturers of medical devices are required to file a special 510(k) device modification when making modifications to an existing device.

How to fill out special 510k device modification?

To fill out a special 510(k) device modification, manufacturers must provide detailed information on the specific modifications made to the device, supporting data and test results, and any other relevant information requested by the FDA.

What is the purpose of special 510k device modification?

The purpose of a special 510(k) device modification is to demonstrate that the modifications made to an existing device do not affect its safety and effectiveness, and that the device still complies with the regulatory requirements.

What information must be reported on special 510k device modification?

Information reported on a special 510(k) device modification includes the specific modifications made to the device, supporting data and test results, any labeling changes, and any other relevant information as requested by the FDA.