Get the free Section C 510k Summary 510K Summary - accessdata fda

FES Section C 510(k) Summary 510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. “The

How to fill out section c 510k summary

How to fill out section c 510k summary:

1. Start by providing a concise and clear summary of the intended use and indication for use of the medical device. This should explain the purpose of the device and the medical condition it is designed to address.
2. Include a description of the technology or methodology used in the device. Explain how the device is designed and how it functions. Provide details about any unique features or capabilities it may have.
3. Outline the device's performance characteristics. This should include information on its accuracy, precision, sensitivity, specificity, and any other relevant performance metrics. If applicable, provide data from tests or studies that demonstrate these characteristics.
4. Discuss any substantial equivalence to previously cleared devices. If the device is similar to others already on the market, explain how it compares and whether there are any differences or improvements.
5. Provide a comprehensive summary of the non-clinical testing conducted on the device. This should include details about any biocompatibility, sterility, electrical safety, mechanical testing, or other relevant evaluations that have been performed.
6. If applicable, include a summary of any clinical investigations or studies conducted on the device. Describe the design of the studies, the patient population involved, the endpoints measured, and the results obtained.

Who needs section c 510k summary:

1. Medical device manufacturers who are submitting a 510k premarket notification to the U.S. Food and Drug Administration (FDA) for marketing clearance of their device.
2. Regulatory affairs professionals who are responsible for preparing the submission documents and ensuring compliance with FDA regulations.
3. Healthcare professionals and experts who review and evaluate the safety and effectiveness of medical devices before they are cleared for marketing.

In summary, filling out section c 510k summary involves providing a clear and concise description of the device's intended use, technology, performance characteristics, substantial equivalence, as well as non-clinical and clinical testing. This information is essential for medical device manufacturers, regulatory affairs professionals, and healthcare experts involved in the FDA clearance process.

For pdfFiller’s FAQs

What is section c 510k summary?

Section C 510(k) summary is a concise summary of the information related to a medical device and its substantial equivalence to a predicate device.

Who is required to file section c 510k summary?

The manufacturer or applicant of a medical device seeking FDA clearance is required to file Section C 510(k) summary.

How to fill out section c 510k summary?

Section C 510(k) summary should be filled out by providing a brief description of the device, its technological characteristics, and how it is substantially equivalent to a predicate device.

What is the purpose of section c 510k summary?

The purpose of Section C 510(k) summary is to provide a snapshot of the key information about the medical device to the FDA reviewers for clearance decision.

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

Section C 510(k) summary must include device description, technological characteristics, and a comparison to a predicate device.

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