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This 510(k) summary provides safety and effectiveness information for Shandong Yinghong Medical Products Co., Ltd.'s Synthetic Nitrile Patient Examination Gloves, which are powder-free and blue in

How to fill out 510 k summary

To fill out a 510(k) summary, follow these steps:

1. Review the FDA's guidance document: Familiarize yourself with the FDA's specific guidelines and requirements for preparing a 510(k) summary. This document provides detailed instructions and examples to help you navigate the process.
2. Identify the intended use and indications for use: Clearly state the intended use of the medical device, including any specific indications for use. Be precise and comprehensive in describing the purpose and function of the device.
3. Provide a device description: Describe the device in detail, including its components, materials, and manufacturing process. Include any relevant specifications, such as size, weight, and performance characteristics.
4. Discuss the technological characteristics: Explain the scientific principles or methodologies employed by the device. Highlight any unique features or novel technology utilized, comparing it to similar devices already on the market.
5. Outline the scientific evidence supporting substantial equivalence: Present scientific data, test results, and clinical evaluations that demonstrate the device's substantial equivalence to a legally marketed predicate device. Make sure to include biocompatibility and performance data, as well as any supporting literature or studies.
6. Address any risks and mitigations: Identify potential risks associated with the device and explain how they are mitigated through design features, manufacturing controls, labeling, or instructions for use. Provide an assessment of these risks and demonstrate that the benefits outweigh any potential harms.
7. Include a summary of any nonclinical or clinical testing: Briefly summarize the results and conclusions of any nonclinical or clinical studies conducted on the device. Use clear language and avoid technical jargon to ensure the summary is easily understandable.
8. Compile necessary documentation and references: Gather all the relevant documentation, including test reports, labeling, drawings, and certificates. Cite all sources used for scientific evidence and literature references in the proper format.

Who needs a 510(k) summary?

1. Medical device manufacturers: Companies or individuals intending to market a new medical device or make significant modifications to an existing one need to prepare a 510(k) summary as part of their premarket notification to the FDA.
2. Regulatory affairs professionals: Professionals specializing in regulatory affairs are responsible for ensuring compliance with FDA regulations and guidelines. They are typically involved in preparing and submitting the 510(k) summary for medical devices.
3. FDA reviewers: The FDA reviewers and assessors are the target audience for the 510(k) summary. They rely on the information provided in the summary to evaluate whether the device meets the requirements for substantial equivalence and regulatory approval.

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What is 510 k summary?

The 510(k) summary is a document submitted to the United States Food and Drug Administration (FDA) as part of the premarket notification process for medical devices. It provides a concise description of the device and its intended use, along with any similarities to previously cleared or marketed devices.

Who is required to file 510 k summary?

Manufacturers or distributors who intend to market a medical device in the U.S. and are not exempt from the 510(k) requirements as determined by the FDA, are required to file a 510(k) summary.

How to fill out 510 k summary?

To fill out a 510(k) summary, manufacturers or distributors need to provide a concise description of the device, its intended use, and any comparisons to previously cleared or marketed devices. Additional information such as performance testing results, risk assessments, and clinical data may also be required depending on the device and its intended use.

What is the purpose of 510 k summary?

The purpose of the 510(k) summary is to demonstrate that a medical device is substantially equivalent to a legally marketed device and that it poses no significant risk to public health. It assists the FDA in evaluating the safety and effectiveness of the device before allowing it to be marketed in the U.S.

What information must be reported on 510 k summary?

The 510(k) summary should include information such as device description, intended use, technological characteristics, comparisons to legally marketed devices, performance testing results, risk assessments, and clinical data if applicable. It should provide sufficient evidence to support the claim of substantial equivalence to a predicate device.