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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K171441 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. To fill out a 510k substantial equivalence determination, follow these steps:
2. Gather all relevant information about your medical device, including its intended use, indications for use, technical specifications, and any testing or clinical data.
3. Identify the predicate device(s) that you intend to compare your device to. These should be legally marketed devices in the United States that have been cleared through the 510(k) process.
4. Conduct a thorough comparison between your device and the predicate device(s). This should include a detailed analysis of their similarities and differences in terms of design, materials, performance, and intended use.
5. Summarize the results of the comparison in a substantial equivalence determination. This should clearly demonstrate how your device is as safe and effective as the predicate device(s) and why any differences do not affect its safety and efficacy.
6. Prepare any additional documentation required by the U.S. Food and Drug Administration (FDA), such as risk assessments, biocompatibility studies, or performance testing results.
7. Complete the FDA's Form 510(k), providing all necessary information about your device, its intended use, and the substantial equivalence determination.
8. Submit the completed 510(k) application to the FDA, along with any supporting documentation and the required user fees.
9. Wait for the FDA's review and clearance decision. This process can take several months and may involve additional requests for information or clarification from the FDA.
10. If your device is cleared through the substantial equivalence determination, you can proceed with marketing and distributing it in the United States.

Who needs 510k substantial equivalence determination?

1. Anyone who intends to market a new medical device in the United States that is not exempted by the FDA needs to obtain a 510k substantial equivalence determination.
2. This includes manufacturers, importers, and distributors of medical devices that are of moderate to high risk and do not have a legally marketed predicate device.
3. The FDA requires this determination to ensure that new devices are safe and effective before they are made available to the public.
4. It is important to note that not all medical devices require a 510k submission. Certain low-risk devices may be exempted from this requirement.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process by which the US FDA determines if a medical device is substantially equivalent to a legally marketed device that does not require premarket approval.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who are seeking FDA clearance to market their devices in the United States 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, manufacturers must provide detailed information about their device, its intended use, similarities to other devices on the market, and any differences that may affect safety or effectiveness.

What is the purpose of 510k substantial equivalence determination?

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

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

Information that must be reported on a 510k substantial equivalence determination includes device descriptions, performance data, labeling, and any known risks associated with the device.