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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k163633 B. Purpose for Submission: New Device C. Measured: Whole blood glycosylated

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. First, gather all the necessary information and documentation related to the medical device.
2. Next, review the guidance documents provided by the FDA for filling out the 510k substantial equivalence determination.
3. Carefully fill out each section of the form, providing accurate and detailed information about the device and its intended use.
4. Include supporting evidence such as testing results, clinical data, and any other relevant information that demonstrates substantial equivalence.
5. Double-check all the filled information and make sure everything is accurate and complete.
6. Submit the filled 510k substantial equivalence determination form along with all the required supporting documents to the FDA for review.
7. Follow up with the FDA if any additional information or clarification is requested.
8. Once the FDA approves the substantial equivalence determination, the medical device can proceed with the necessary regulatory processes.

Who needs 510k substantial equivalence determination?

1. Manufacturers who intend to market a new medical device that does not fall under the category of FDA exemptions.
2. Manufacturers seeking to market a medical device that has modifications or significant changes compared to an existing device already on the market.
3. Manufacturers of medical devices that are subject to pre-market approval requirements by the FDA.
4. Manufacturers of medical devices that are intended to be used in diagnosis, treatment, or prevention of serious health conditions.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is the process by which the FDA compares a new medical device to a previously cleared device to determine if they are substantially equivalent.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices are required to file 510k substantial equivalence determination if they are seeking FDA clearance for a new device.

How to fill out 510k substantial equivalence determination?

To fill out 510k substantial equivalence determination, manufacturers must provide detailed information on the new device, comparative analysis with a similar cleared device, and any supporting data.

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 does not require premarket approval.

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

Information such as device description, intended use, technological characteristics, performance data, labeling, and biocompatibility must be reported on 510k substantial equivalence determination.