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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 February 20, 2015,

How to fill out revised 510k summary

How to Fill Out Revised 510k Summary:

1. Ensure you have all the necessary information and documentation required to complete the revised 510k summary. This includes the details of your medical device, any modifications or changes from the previous submission, and supporting data or studies.
2. Familiarize yourself with the FDA's requirements and guidelines for filling out the revised 510k summary. This will help you understand what information needs to be included and how it should be formatted.
3. Begin by providing a clear and concise summary of the device, its intended use, and any changes or modifications made. This should include information on the safety and effectiveness of the device.
4. Outline the testing and clinical study results that support the safety and efficacy of the device. Include any relevant data, statistical analysis, and conclusions drawn from these studies.
5. Ensure that you address any potential risks or hazards associated with the device and outline the steps taken to mitigate these risks. This could include information on labeling, instructions for use, or additional precautions.
6. Clearly state any differences or deviations from previous submissions, and explain the reasons behind these changes.
7. Include any additional information or supporting documentation that is requested by the FDA. This could include product specifications, labeling, or any other relevant information.
8. Review and proofread the revised 510k summary to ensure accuracy, clarity, and completeness.

Who Needs Revised 510k Summary:

1. Medical device manufacturers who have made modifications or changes to their device that may require a new submission to the FDA.
2. Companies seeking clearance or approval for their medical devices in the United States.
3. Regulatory affairs professionals or consultants who are responsible for preparing and submitting 510k summaries on behalf of the manufacturer.
4. Quality assurance personnel who may be involved in the review and approval process of the revised 510k summary.
5. FDA reviewers who evaluate the safety and effectiveness of medical devices based on the information provided in the revised 510k summary.

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What is revised 510k summary?

The revised 510k summary is a document submitted to the FDA to provide updated information on changes made to a previously cleared medical device.

Who is required to file revised 510k summary?

Manufacturers of medical devices are required to file a revised 510k summary when changes are made to a previously cleared device.

How to fill out revised 510k summary?

The revised 510k summary can be filled out by providing detailed information on the changes made to the device, including design changes, labeling updates, and any new testing results.

What is the purpose of revised 510k summary?

The purpose of the revised 510k summary is to inform the FDA of any changes made to a medical device that may affect its safety or efficacy.

What information must be reported on revised 510k summary?

The revised 510k summary must include information on the changes made to the device, any new test results, updated labeling, and any new risks or benefits associated with the device.