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510K Notification Supplement K101893 S/1ior December 31, 2011 510k SUMMARY (as per 21 CFIX807.92(b) (1) FE5 1720GENERAL INFORMATION Device Generic Name: Trade Name:Nexus Nexus Nexus NexusInfrared

How to fill out 510k notification supplement

How to fill out 510k notification supplement:

1. Begin by reviewing the instructions provided with the 510k notification supplement. It is important to familiarize yourself with the specific requirements and details mentioned in the instructions.
2. Collect all the necessary information and documentation required for the notification supplement. This may include data on the device, its intended use, any previous submissions or clearances, and any changes or modifications being made.
3. Complete the administrative section of the notification supplement. This typically involves providing general information about the manufacturer, contact details, and a brief description of the device.
4. Provide a comprehensive description of the device in the technical section. This should include details about its intended use, design specifications, components, and any relevant performance testing or clinical data.
5. If any changes have been made to the device or its manufacturing process, include this information in the appropriate section. Clearly explain the nature of the changes and their potential impact on the safety and performance of the device.
6. Include a well-structured and thorough risk analysis that addresses any potential hazards associated with the device. This should cover aspects such as design, materials, manufacturing, and intended use.
7. Provide a summary of any validation testing conducted to demonstrate the safety and effectiveness of the device. Include details of the testing methods, results, and any necessary explanations or justifications.
8. If applicable, include any labeling changes or updates that have been made to the device. This may involve providing revised instructions for use, warnings, or precautions.
9. Review and double-check all the information provided in the notification supplement to ensure accuracy and completeness. Make sure that all required sections have been properly addressed and that all necessary attachments or supporting documentation have been included.
10. Finally, submit the completed 510k notification supplement to the appropriate regulatory authority or agency. Follow their specific submission guidelines and ensure that all required forms and fees are included.

Who needs 510k notification supplement?

1. Medical device manufacturers who intend to introduce a new medical device into the US market that requires premarket notification, as outlined by the Food and Drug Administration (FDA), need the 510k notification supplement.
2. Manufacturers who have made any significant changes or modifications to an existing FDA-cleared medical device may also need to submit a 510k notification supplement to provide the necessary documentation and information about the changes made.
3. Additionally, manufacturers who have previously received a 510k clearance for a similar device but are now introducing a different model or design may also be required to submit a 510k notification supplement. This is to ensure that the new device complies with the necessary regulations and requirements for market entry.

For pdfFiller’s FAQs

What is 510k notification supplement?

A 510k notification supplement is a submission to the FDA that provides additional information or data related to a previously cleared 510k medical device.

Who is required to file 510k notification supplement?

Manufacturers of medical devices who have already obtained 510k clearance and need to make changes or provide additional information are required to file a 510k notification supplement.

How to fill out 510k notification supplement?

To fill out a 510k notification supplement, manufacturers must provide detailed information about the changes or additional data being submitted, along with any supporting documentation.

What is the purpose of 510k notification supplement?

The purpose of a 510k notification supplement is to inform the FDA of changes or additions to a previously cleared medical device to ensure continued safety and effectiveness.

What information must be reported on 510k notification supplement?

Information required on a 510k notification supplement includes details of the changes being made, any new data or testing results, and how these changes impact the safety and effectiveness of the device.

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