Get the free 510 (k) SUMMVARY

JAN 282009 NUV0.INC.k930rc510 (k) SUMMARY Submitter:No Inc 5368 Kohl Road Erie, PA 16407Contact Person:Curt Wander SchaaffTrade Name:Verde LED Surgical Lighting SystemCommon Name:Light Surgical, Ceiling

How to fill out 510 k summvary

How to fill out 510 k summvary

1. Start by obtaining the necessary information about the medical device that requires a 510(k) summary.
2. Carefully review the 510(k) summary guidelines provided by the Food and Drug Administration (FDA).
3. Gather all the relevant documentation, including the device description, intended use, indications for use, and labeling information.
4. Compose the summary in a point-by-point format, clearly addressing each section required by the FDA.
5. Include a concise description of the device, its intended use, and how it compares to predicate devices.
6. Provide evidence of substantial equivalence, demonstrating that the new device is as safe and effective as the predicate device.
7. Ensure that the summary is well-written, organized, and free from errors or ambiguity.
8. Proofread the summary thoroughly before submission to ensure accuracy and completeness.
9. Submit the completed 510(k) summary to the FDA through the appropriate channels.
10. Monitor for any updates or requests for additional information from the FDA.
11. Maintain accurate records of the 510(k) summary for future reference and compliance purposes.

Who needs 510 k summvary?

1. Manufacturers of medical devices that are introducing a new device to the market.
2. Manufacturers of modifications or significant changes to existing devices that may affect safety or effectiveness.
3. Those seeking clearance or approval from the FDA to market a medical device in the United States.
4. Individuals or companies involved in the development, production, or distribution of medical devices.
5. Regulatory affairs professionals and consultants responsible for ensuring compliance with FDA regulations.
6. Healthcare organizations, hospitals, and clinics that use medical devices and require information on their safety and effectiveness.
7. Patients and healthcare providers who rely on accurate information about medical devices to make informed decisions.

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What is 510 k summary?

A 510(k) summary is a concise description of the safety and effectiveness of a medical device that has been cleared for marketing by the FDA.

Who is required to file 510 k summary?

Manufacturers who intend to market a new medical device are required to submit a 510(k) summary to the FDA.

How to fill out 510 k summary?

To fill out a 510(k) summary, manufacturers must provide detailed information on the device along with data on its safety and effectiveness.

What is the purpose of 510 k summary?

The purpose of a 510(k) summary is to demonstrate that a new medical device is substantially equivalent to a legally marketed device and does not pose any new risks to patients.

What information must be reported on 510 k summary?

Information such as device description, intended use, technological characteristics, materials, performance data, and labeling must be reported on a 510(k) summary.