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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k182593 B. Purpose for Submission: New Device C. Measured: Ketone, as betahydroxybutyrate,

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out a 510k substantial equivalence determination, follow these steps:
2. Obtain a copy of the 510k substantial equivalence determination form from the FDA website.
3. Provide basic information about the medical device for which you are seeking determination.
4. Detail the intended use, technological characteristics, and performance features of the device.
5. Include information about any predicate devices that the new device is compared to.
6. Provide evidence, such as test reports and clinical studies, to demonstrate substantial equivalence.
7. Submit the filled-out form, along with all supporting documents, to the FDA for review.
8. Wait for the FDA's decision regarding substantial equivalence determination.
9. If approved, you can proceed with marketing the medical device in the United States.

Who needs 510k substantial equivalence determination?

1. Anyone who wants to market a new medical device in the United States that is not exempted from premarket notification requirements needs to obtain a 510k substantial equivalence determination. This includes manufacturers, importers, and distributors of medical devices.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a regulatory process by which the FDA evaluates whether a new medical device is equivalent to a previously marketed device. This allows the new device to be marketed without requiring extensive clinical trials.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who wish to market a device that is not significantly different from an already legally marketed device must file a 510(k) substantial equivalence determination with the FDA.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, a manufacturer must gather relevant information about the device, including its intended use, design, materials, and performance data, then complete the FDA's 510(k) submission form and provide any supporting documentation required.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to ensure that new medical devices are safe and effective based on their equivalence to previously cleared devices, thereby streamlining the approval process and ensuring timely access to useful medical technologies.

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

The information that must be reported in a 510(k) substantial equivalence determination includes device identification, indications for use, technological characteristics, performance testing results, labeling, and a comparison with a predicate device.