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How to fill out 510k summary as required

How to fill out 510(k) Summary as Required by 21 CFR 807.92

1. Identify the device: Clearly describe the medical device for which the 510(k) is being submitted.
2. Indicate the intended use: Provide details about the device's intended use and indications.
3. Describe the technological characteristics: Explain the design, materials, and performance specifications involving comparisons to a predicate device.
4. Provide performance data: Include results from any nonclinical and clinical testing that supports the device's safety and effectiveness.
5. Include labeling: Present any labels and instructions for use that will accompany the device.
6. Summarize conclusions: Clearly state why the device is substantially equivalent to a predicate device.
7. Review for completeness: Ensure all required items listed in 21 CFR 807.92 are addressed.

Who needs 510(k) Summary as Required by 21 CFR 807.92?

1. Manufacturers of medical devices who seek to market products that are not significantly different from existing devices.
2. Companies looking for a regulatory pathway to demonstrate that their device is safe and effective in comparison to a predicate.
3. Organizations involved in the innovation and development of medical technologies that require FDA clearance before marketing.

People Also Ask about

What does FDA 510k cleared mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is required for 510k submission?

Device classes & premarket requirements that determine 510k vs PMA Class I: These devices are simple, with minimal risk to the user. Class II: Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification (510k submission) before they can be legally marketed.

What does FDA granted 510 K clearance mean?

The documentation must include drawings, schematics, and a description of the device's intended use and performance. Selection of the most appropriate predicate device — The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.

What is FDA 510k certification?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Learn more Search Database. Help Download Files. 510K

What is the 510k summary?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What happens after 510k approval?

Once a device receives clearance, a company has 30 days to register the device with the FDA. If the company is new and has no devices on the market, it must also register as an establishment with the FDA, which incurs an annual fee. Some firms are surprised to learn that additional fees are involved in this process.

What is the difference between FDA and FDA 510k?

The Function Of FDA And FDA 510k? The FDA develops rules and criteria for certifying items such as medical devices, medicines, and biological substances to assure their safety for the general population. The FDA 510k must be implemented for healthcare products designated as class 2 or certain class 1 technologies.

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What is 510(k) Summary as Required by 21 CFR 807.92?

The 510(k) Summary is a document submitted to the FDA that provides a comprehensive overview of a medical device's safety and effectiveness, demonstrating that the device is substantially equal to a legally marketed device.

Who is required to file 510(k) Summary as Required by 21 CFR 807.92?

Manufacturers of medical devices that are intended for commercial distribution and require premarket notification must file a 510(k) Summary.

How to fill out 510(k) Summary as Required by 21 CFR 807.92?

To fill out the 510(k) Summary, manufacturers must include detailed information about the device, including its intended use, technological characteristics, labeling, and data showing substantial equivalence to a predicate device.

What is the purpose of 510(k) Summary as Required by 21 CFR 807.92?

The purpose of the 510(k) Summary is to provide the FDA and the public with information about the device, facilitate the regulatory review process, and ensure that it meets safety and efficacy standards.

What information must be reported on 510(k) Summary as Required by 21 CFR 807.92?

The 510(k) Summary must report information such as the submitter's name and address, device trade name, common name, classification, intended use, technological characteristics, comparison to predicate devices, and any performance data.