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Summary of Safety and Effectiveness 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 assigned

How to fill out 510 k summary of

How to fill out a 510(k) summary:

1. Begin by providing a brief introduction that clearly identifies the medical device in question and its intended use. This section should also mention any similar devices already on the market.
2. Next, outline the predicate device(s) that will be used for comparison. Include detailed information about the predicate device(s), such as their intended use, technological characteristics, and any relevant performance data.
3. Provide a clear and concise description of the medical device under consideration. Include information about its design, materials, intended use, and any specific features or modifications that differentiate it from the predicate device(s).
4. Discuss any non-clinical testing that has been conducted to evaluate the safety and performance of the medical device. Include details about the testing methods, results, and any conclusions or recommendations based on the findings.
5. Detail any clinical studies or investigations that have been conducted to evaluate the device's safety and effectiveness. Include information about the study design, patient population, endpoints, and results. If no clinical studies have been conducted, provide a justification for not conducting them.
6. Include a summary of the labeling or instructions for use that will accompany the medical device. This should cover topics such as indications for use, warnings and precautions, and information for healthcare professionals and patients.
7. Lastly, provide a comprehensive discussion that summarizes the supporting data, identifies any potential risks or limitations of the device, and offers a conclusion about the safety and effectiveness of the medical device.

Who needs a 510(k) summary:

1. Manufacturers: Medical device manufacturers who want to introduce a new device to the U.S. market are required to submit a 510(k) premarket notification to the Food and Drug Administration (FDA). As part of the submission, a 510(k) summary must be included to provide a concise overview of the device, its intended use, and supporting data.
2. FDA Reviewers: FDA reviewers rely on the 510(k) summary to quickly assess the safety and effectiveness of the medical device. It enables them to evaluate the device against similar predicate devices and make informed decisions regarding its clearance for market entry.
3. Healthcare Professionals: Healthcare professionals, such as doctors, nurses, and medical technicians, may need access to the 510(k) summary to understand the capabilities, limitations, and risks associated with a specific medical device. This information helps them make informed decisions about device selection and use.
4. Patients: Patients who are considering undergoing a medical procedure or treatment involving a specific medical device may benefit from reviewing the 510(k) summary. It allows them to gain insights into the device's safety and effectiveness, as well as any potential risks or limitations that may affect their healthcare choices.

Overall, the 510(k) summary serves as an essential document that facilitates communication between manufacturers, regulatory authorities, healthcare professionals, and patients. It plays a crucial role in ensuring the safety and effectiveness of medical devices in the market.

For pdfFiller’s FAQs

What is 510 k summary of?

The 510(k) summary is a brief overview of a medical device submission that summarizes the essential elements, including the technological characteristics of the device.

Who is required to file 510 k summary of?

Manufacturers who are seeking clearance to market a new medical device in the United States are required to file a 510(k) summary.

How to fill out 510 k summary of?

To fill out a 510(k) summary, manufacturers must provide a concise description of the device, its intended use, and its technological characteristics, along with any applicable performance data.

What is the purpose of 510 k summary of?

The purpose of a 510(k) summary is to provide a high-level overview of a medical device submission to the FDA, allowing for a quick and efficient review process.

What information must be reported on 510 k summary of?

The 510(k) summary must include a description of the device, its intended use, a comparison to a predicate device, any performance data, and any labeling information.

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