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510(k) SUMMARY Contact Information:Mary Ann Sirius Director, New Product & Business Development Microbiology North America Thermos Fisher Scientific Rebel Products 12076 Santa Fe Drive Lenexa, KS

How to fill out 510k summary

How to fill out 510k summary

1. Start by gathering all relevant information and documentation related to the medical device being submitted for 510k clearance.
2. Identify the specific sections and components of the 510k summary that need to be completed.
3. Begin by providing a concise and accurate description of the device, including its intended use and indications for use.
4. Include a detailed summary of the device's technological characteristics, design, and performance.
5. Provide a comprehensive list of any similar devices already on the market, highlighting any similarities or differences in design and functions.
6. Include a thorough risk assessment, addressing any potential hazards and risks associated with the device.
7. Present the results of any performance testing or clinical studies conducted on the device.
8. Discuss any labeling requirements, including instructions for use and any warnings or precautions.
9. Finally, review the completed 510k summary for accuracy and completeness before submitting it for regulatory review.
10. It is recommended to seek guidance from regulatory experts or consultants to ensure compliance with all applicable regulations and requirements.

Who needs 510k summary?

1. Manufacturers of medical devices that intend to market their products in the United States need to provide a 510k summary.
2. Any company or individual planning to introduce a new medical device or make changes to an existing device that requires clearance from the U.S. Food and Drug Administration (FDA) must submit a 510k summary.
3. Healthcare professionals, researchers, and regulatory authorities may also refer to the 510k summary to evaluate the safety and effectiveness of a medical device.

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What is 510k summary?

510k summary is a concise document submitted to the FDA to demonstrate substantial equivalence of a new medical device to a predicate device.

Who is required to file 510k summary?

Manufacturers or distributors of medical devices seeking FDA approval for marketing in the United States.

How to fill out 510k summary?

The 510k summary must include information on the device description, intended use, technological characteristics, performance data, and comparison to predicate device.

What is the purpose of 510k summary?

The purpose of 510k summary is to demonstrate that a new medical device is as safe and effective as a legally marketed device (predicate device) and therefore can be cleared for marketing by the FDA.

What information must be reported on 510k summary?

Information on device description, intended use, technological characteristics, performance data, and comparison to predicate device.