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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Begin by reviewing the FDA's guidance document for substantial equivalence determination under the 510k process.
2. Familiarize yourself with the requirements and criteria for demonstrating substantial equivalence.
3. Collect all necessary documentation and information related to the device for which you are seeking substantial equivalence determination.
4. Prepare a detailed comparison of your device with a legally marketed predicate device, highlighting both similarities and differences.
5. Clearly identify any technological differences and explain how they do not impact safety and effectiveness.
6. Include relevant performance data, test reports, and clinical studies to support your claim of substantial equivalence.
7. Complete the 510k submission form, providing accurate and comprehensive information about your device and the predicate device.
8. Submit the completed 510k submission to the FDA, including all required fees and supporting documents.
9. Await the FDA's review and response regarding the substantial equivalence determination.
10. If requested by the FDA, provide additional information or clarify any issues raised during the review process.
11. Comply with any further requests or requirements from the FDA to ensure a successful determination.
12. Once the FDA has made a determination, carefully review the decision and take appropriate actions as necessary.

Who needs 510k substantial equivalence determination?

1. Medical device manufacturers who intend to market a new device that does not qualify for an exemption or falls under a different regulatory pathway.
2. Manufacturers who aim to make changes to an existing device that may impact safety and effectiveness, requiring a new substantial equivalence determination.

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What is 510k substantial equivalence determination?

The 510k substantial equivalence determination is a process used by the FDA to evaluate whether 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 new medical devices are required to file a 510k substantial equivalence determination with the FDA.

How to fill out 510k substantial equivalence determination?

The 510k substantial equivalence determination must be filled out with detailed information about the new device, its intended use, and how it compares to the predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510k substantial equivalence determination is to demonstrate that the new device is as safe and effective as the predicate device.

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

The 510k substantial equivalence determination must include information on the design, materials, performance, and intended use of the new device, as well as any differences from the predicate device.