Get the free A summary of 510(k) safety and effectiveness information in accordance with the requ...

Float 22 2o12 510(k) SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 Submitter Information Name Address Biome Manufacturing Corp.

How to fill out a summary of 510k

How to fill out a summary of 510k

1. To fill out a summary of 510k, follow these steps:
2. Start by gathering all the necessary information about the medical device being submitted for 510k clearance.
3. Begin the summary by providing a concise description of the device and its intended use.
4. Include information about the intended patient population and any special considerations for use.
5. Provide a detailed summary of the device's scientific, technical, and functional characteristics.
6. Include a list of all components, materials, and manufacturing processes used in the device.
7. Summarize any clinical testing or performance data that supports the device's safety and effectiveness.
8. Clearly state any indications for use, contraindications, warnings, and precautions.
9. Describe any similar devices already on the market and explain how the new device differs.
10. Review and revise the summary to ensure accuracy and clarity.
11. Finally, submit the completed summary along with the rest of the 510k application for review by the appropriate regulatory agency.

Who needs a summary of 510k?

1. A summary of 510k is needed by medical device manufacturers who are seeking clearance to market their devices in the United States.
2. It is a required component of the 510k submission process regulated by the U.S. Food and Drug Administration (FDA).
3. Any manufacturer introducing a new medical device or making significant modifications to an existing device needs to provide a summary of 510k.

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What is a summary of 510k?

A summary of 510k is a regulatory document submitted to the FDA by manufacturers seeking clearance to market a medical device. It demonstrates that the device is safe and effective by comparing it to a legally marketed device.

Who is required to file a summary of 510k?

Any medical device manufacturer who wants to market a device that is not significantly different from an existing, cleared device is required to file a summary of 510k.

How to fill out a summary of 510k?

To fill out a summary of 510k, manufacturers must provide information including the device's intended use, technological characteristics, and comparisons to predicate devices. Detailed instructions can be found on the FDA's website.

What is the purpose of a summary of 510k?

The purpose of a summary of 510k is to provide the FDA with sufficient information to determine whether the device is substantially equivalent to a predicate device, thus facilitating timely access to safe and effective medical devices.

What information must be reported on a summary of 510k?

A summary of 510k must report device identification, intended use, descriptions of technological characteristics, performance data, and labeling information. Additionally, it should include reasons supporting substantial equivalence to a predicate device.