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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: K170143 B. Purpose for Submission: New Device C. Measured: Capillary hold blood

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. Gather all necessary information and documents.
3. Identify the predicate device against which the substantial equivalence will be determined.
4. Review the guidance documents provided by the FDA for filling out the 510k form.
5. Complete each section of the form accurately and thoroughly.
6. Provide all supporting documentation and evidence of substantial equivalence.
7. Double-check the form for completeness and accuracy.
8. Submit the filled-out form along with the required fees to the FDA.
9. Wait for the FDA's review and decision regarding the substantial equivalence determination.
10. If additional information or clarification is needed, respond promptly and provide the requested materials.
11. Follow up with the FDA for any further instructions or actions required.

Who needs 510k substantial equivalence determination?

1. Any manufacturer who intends to market a medical device that is not exempted from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act needs to obtain a 510k substantial equivalence determination.
2. Healthcare facilities and distributors who provide medical devices also need to ensure that the devices they distribute have undergone this determination.
3. It is essential for maintaining compliance with regulatory requirements and ensuring patient safety.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process used by the FDA to determine if a new medical device is as safe and effective as a legally marketed device that is already on the market.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who intend to market a new device in the U.S. 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, including its intended use, design, materials, and testing data.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to demonstrate that a new medical device is at least as safe and effective as a device that is already legally marketed.

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

The 510(k) substantial equivalence determination must include information about the new device's intended use, technological characteristics, performance data, and any similarities to legally marketed devices.