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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: K163390 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 510k substantial equivalence determination, follow these steps:
2. Begin by carefully reviewing the guidance documents provided by the FDA regarding the 510k substantial equivalence determination process.
3. Collect all necessary information related to your device and its intended use, including technical specifications, performance data, and labeling.
4. Identify a predicate device that is already on the market and is substantially equivalent to your device. This will serve as a reference point for the evaluation.
5. Compare the technological characteristics, intended use, and performance of your device with the predicate device. Document the similarities and differences.
6. Prepare a detailed summary of the comparison, highlighting the aspects of your device that demonstrate substantial equivalence to the predicate device.
7. Provide scientific and clinical justification for any differences between your device and the predicate device, explaining why these differences do not affect the safety and effectiveness of your device.
8. Compile all the necessary supporting documentation, including testing results, clinical study reports, and any other relevant data.
9. Fill out the 510k substantial equivalence determination form provided by the FDA, ensuring that all the required information is accurately and completely provided.
10. Submit the completed form and accompanying documentation to the FDA for evaluation.
11. Follow up with the FDA for any additional requests for information or clarification. Cooperate fully with their review process.
12. Note: It is advisable to seek legal and regulatory guidance to ensure compliance with all FDA requirements throughout the entire process.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor of medical devices that are new or modified, and intended for commercial distribution in the United States, may need to obtain a 510k substantial equivalence determination.
2. The determination is required by the FDA to establish that the new or modified device is as safe and effective as a legally marketed predicate device.
3. Therefore, companies seeking to introduce or bring modifications to medical devices that may require clearance from the FDA should go through the 510k substantial equivalence determination process.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a regulatory process used by the FDA to evaluate whether a new medical device is substantially equivalent to an already legally marketed device.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that intend to market a new device that is not exempt from premarket notification requirements must 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 complete the FDA's 510(k) submission form, provide detailed device descriptions, indicate intended use, and compare the new device to a predicate device.

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 safe and effective and that it is as safe and effective as a device that is already on the market.

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

The 510(k) submission must report device description, intended use, labeling, performance data, and information on the predicate device for comparison.