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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k162698 B. Purpose for Submission: New device C. Measured: Thyroid stimulating

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Start by gathering all the necessary information and documentation for the 510k substantial equivalence determination.
2. Review the guidance documents and regulations provided by the FDA to understand the requirements and proper procedure for filling out the 510k form.
3. Obtain a copy of the current product code for the device you are seeking substantial equivalence determination for.
4. Provide a detailed description of your device, including its intended use, technological characteristics, and performance data.
5. Conduct a thorough comparison of your device to a legally marketed predicate device that is already FDA cleared.
6. Identify and address any differences between your device and the predicate device, highlighting how these differences do not affect the safety and effectiveness of your device.
7. Prepare a comprehensive summary of the scientific and technical evidence that supports your claim of substantial equivalence.
8. Include any additional information or data requested by the FDA in the 510k form.
9. Review and double-check all the information provided in the form for accuracy and completeness.
10. Submit the completed 510k form along with the required fees to the FDA for review and evaluation.

Who needs 510k substantial equivalence determination?

1. Manufacturers of medical devices who intend to introduce a new device to the market that does not fall under the category of devices exempt from premarket notification requirements.
2. Manufacturers whose device has undergone significant changes or modifications that may affect its safety and effectiveness.
3. Manufacturers of devices that have previously received 510k clearance for a different indication, and now want to use the device for a new indication or purpose.
4. Any manufacturer who is unsure whether their device requires a 510k substantial equivalence determination should consult the FDA or a qualified regulatory professional for guidance.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that are introducing a new device to the market or making significant changes to an existing device are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, manufacturers must provide detailed information about the new device, compare it to a predicate device, and demonstrate that it is substantially equivalent.

What is the purpose of 510k substantial equivalence determination?

The purpose of a 510(k) substantial equivalence determination is to demonstrate to the FDA that the new medical device is as safe and effective as a legally marketed device, without the need for additional clinical data.

What information must be reported on 510k substantial equivalence determination?

The 510(k) substantial equivalence determination must include information about the new device, its intended use, its technological characteristics, and how it compares to a predicate device.