Get the free Premarket Notification 510(k) Summary This summary of 510(k) safety and effectivenes...

Premarket Notification 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 assigned

How to fill out premarket notification 510k summary

How to fill out premarket notification 510k summary?

1. Familiarize yourself with the requirements: Read the FDA's guidance document on the premarket notification 510k process and familiarize yourself with the specific requirements for the summary section.
2. Provide a concise description of the device: Clearly and accurately describe the device, including its intended use, indications for use, and technological characteristics.
3. Include a comparison to legally marketed devices: Identify any predicate devices that are similar to yours and provide a detailed comparison, highlighting similarities and differences in design, performance, and safety.
4. Explain any deviations from consensus standards: If your device does not conform to any recognized consensus standards, explain why and provide data to support its safety and effectiveness.
5. Include performance data: Present any performance data or testing results that demonstrate the device meets the appropriate standards and is safe and effective for its intended use.
6. Submit a complete and well-organized summary: Ensure that the summary is comprehensive, organized, and follows the required format as outlined by the FDA.

Who needs premarket notification 510k summary?

1. Manufacturers of medical devices: Any manufacturer seeking to commercially distribute a medical device that requires FDA clearance must submit a premarket notification 510k summary.
2. Companies introducing new devices or modifications: If a company is introducing a new medical device into the market or making significant modifications to an existing device, they need to submit a premarket notification 510k summary.
3. Foreign manufacturers exporting to the U.S.: Even foreign manufacturers who want to export their medical devices to the U.S. market must comply with the premarket notification 510k requirements and submit a summary for FDA review and clearance.

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What is premarket notification 510k summary?

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

Who is required to file premarket notification 510k summary?

Manufacturers or sponsors of medical devices are required to file premarket notification 510k summary with the FDA.

How to fill out premarket notification 510k summary?

To fill out premarket notification 510k summary, the manufacturer or sponsor needs to provide detailed information about the new device, its intended use, performance data, and a comparison to a predicate device.

What is the purpose of premarket notification 510k summary?

The purpose of premarket notification 510k summary is to demonstrate that a new medical device is safe and effective and is substantially equivalent to a legally marketed device.

What information must be reported on premarket notification 510k summary?

Premarket notification 510k summary must include detailed information about the new device's design, intended use, performance data, labeling, and a comparison to a predicate device.