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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CIA

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Before starting to fill out the 510k substantial equivalence determination form, make sure you have all the necessary documents and information at hand.
2. Review the FDA guidance documents related to substantial equivalence determination to ensure you understand the requirements and process.
3. Carefully read the instructions provided with the form to ensure you complete it correctly.
4. Start by filling out the basic information section, including the device description, intended use, and indications for use.
5. Provide details about the predicate device(s) you are comparing your device to, including their manufacturer, model name, and 510k number, if available.
6. Describe the technological characteristics of your device and explain how it is similar to or different from the predicate device(s).
7. Include any performance data or test results that demonstrate the substantial equivalence of your device to the predicate device(s).
8. Attach any supporting documentation, such as test reports, labeling, or design drawings, as required.
9. Review the completed form for accuracy and completeness before submitting it to the FDA.
10. Keep a copy of the submitted form and supporting documentation for your records.

Who needs 510k substantial equivalence determination?

1. Manufacturers of medical devices that are new to the market or have undergone significant modifications requiring FDA clearance or approval need to complete 510k substantial equivalence determination.
2. Companies planning to introduce medical devices that are similar to already marketed devices but have technological or performance differences also need to undergo 510k substantial equivalence determination.
3. It is advisable to consult with a regulatory expert or legal counsel to determine if your specific medical device requires 510k substantial equivalence determination.

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What is 510k substantial equivalence determination?

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 of medical devices seeking marketing clearance in the US are required to file 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, manufacturers must provide information on the new device, predicate device, labeling, and performance testing results.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to demonstrate that a new device is as safe and effective as a legally marketed device.

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

Information on device description, intended use, labeling, materials, engineering design, and performance testing must be reported on 510k substantial equivalence determination.