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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k171521 B. Purpose for Submission: New Device C. Measured: Measurement of the

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out the 510k substantial equivalence determination, follow these steps:
2. Start by gathering all the necessary information and documents related to your medical device.
3. Familiarize yourself with the regulations and guidelines provided by the Food and Drug Administration (FDA) for determining substantial equivalence.
4. Identify the predicate device that you believe is substantially equivalent to your own device. This is a similar device that has already been approved by the FDA.
5. Conduct a thorough comparison between your device and the predicate device, considering factors such as intended use, technological characteristics, materials, design, and performance.
6. Prepare a comprehensive written explanation of the similarities and differences between your device and the predicate device. This should include any scientific or clinical data that supports the claim of substantial equivalence.
7. Fill out the 510k substantial equivalence determination form provided by the FDA. Provide accurate and detailed information about your device, the predicate device, and the supporting evidence.
8. Submit the completed form to the FDA along with any required additional documentation and fees.
9. Wait for the FDA's review and feedback. They may request additional information or clarification during the review process.
10. If your device is deemed substantially equivalent, you will receive the FDA's approval and can proceed with marketing your device. If not, you may need to provide further evidence or make necessary modifications to meet the requirements.
11. It is recommended to seek professional assistance or consult with regulatory experts to ensure compliance and increase the chances of a successful 510k determination.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor of a medical device that meets the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) may need to obtain a 510k substantial equivalence determination.
2. The FDA requires this determination for devices that are intended for human use and are not exempt from pre-market notification requirements.
3. Common examples of devices that may require a 510k determination include diagnostic equipment, surgical instruments, implantable devices, and certain software applications used for medical purposes.
4. It is important to consult the FDA regulations and guidance documents to determine whether your specific device requires a 510k determination.

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What is 510k substantial equivalence determination?

The 510k 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 or sponsors of medical devices are required to file a 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, companies must provide information on the new medical device, predicate device, and demonstrate the substantial equivalence between the two.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to ensure that new medical devices are safe and effective by comparing them to legally marketed devices.

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

Information such as device description, intended use, technological characteristics, performance data, and risk analysis must be reported on a 510k substantial equivalence determination.