Get the free Section C 510(k) Summary (21 CFR 807.92)- 510(k) Summary

OCT 082008VYz3ASummary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92© The assigned 510(k) number is: Applicant In formation:Date Prepared:July 14, 2008Name:ZONE Medical

How to fill out section c 510k summary

How to fill out section c 510k summary

1. To fill out section c 510k summary, follow these steps:
2. Start by providing a concise description of the device being submitted for review.
3. Describe the intended use of the device and its principal intended actions.
4. Include details about the technological characteristics of the device.
5. Summarize any performance data or clinical testing conducted on the device.
6. Provide information about any labeling or instructions for use that accompany the device.
7. Clearly state any similarities or differences between the device and previously cleared devices.
8. Include any relevant information about potential risks or hazards associated with the device.
9. Conclude the summary by summarizing any additional information or data that is important for the FDA review process.
10. Review the completed section c 510k summary to ensure accuracy and completeness.
11. Submit the filled-out section c 510k summary along with the rest of the 510k application.

Who needs section c 510k summary?

1. The section c 510k summary is needed by medical device manufacturers or their authorized representatives who are submitting a 510k application to the FDA for a new medical device or a significant modification to an existing device.

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What is section c 510k summary?

Section C of the 510(k) summary consists of a detailed description of the medical device intended for submission to the FDA. It includes information such as device classification, the intended use of the device, and any relevant performance data.

Who is required to file section c 510k summary?

Manufacturers of medical devices who are seeking premarket notification from the FDA for their devices are required to file the Section C 510(k) summary.

How to fill out section c 510k summary?

To fill out the Section C 510(k) summary, manufacturers need to provide comprehensive details about their device including device description, intended use, technological characteristics, comparison to predicate devices, and any supporting data such as clinical studies or performance tests.

What is the purpose of section c 510k summary?

The purpose of Section C 510(k) summary is to provide the FDA with relevant information to evaluate the safety and effectiveness of the proposed medical device in comparison to existing, legally marketed devices.

What information must be reported on section c 510k summary?

Information required in the Section C 510(k) summary includes the device name, common name, a description of the device, intended use, technological characteristics, details of any predicate devices, and any supporting evidence of safety and effectiveness.