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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k181588 B. Purpose for Submission: New device C. Measured: Glucose in fresh

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out 510k substantial equivalence determination form, follow these steps:
2. Start by downloading the 510k substantial equivalence determination form from the FDA website.
3. Read the instructions and requirements provided with the form carefully.
4. Fill in the necessary details such as the device name, manufacturer information, and intended use.
5. Provide a detailed description of the device, including its design, materials, and components.
6. Include any performance data, testing results, and clinical studies that support the substantial equivalence of the device to a legally marketed predicate device.
7. If applicable, provide information on any modifications or changes made to the device and justify how they do not affect its substantial equivalence.
8. Attach any additional documentation or supporting evidence, such as labeling, labeling claims, and user manuals.
9. Review the completed form for accuracy and completeness.
10. Sign and date the form, and keep a copy for your records.
11. Submit the filled-out form and all supporting documents to the FDA for review.
12. Await feedback and further instructions from the FDA regarding the determination of substantial equivalence.

Who needs 510k substantial equivalence determination?

1. Manufacturers of medical devices that are considered new and not exempted by the FDA regulations need to obtain 510k substantial equivalence determination.
2. This determination is necessary for devices that have different technological characteristics, intended uses, or are not already legally marketed in the United States.
3. The substantial equivalence determination is required to demonstrate that the new device is safe and effective and can be marketed as a Class II medical device.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process by which the FDA determines whether a new medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who are seeking to introduce a new device to the market are required to file a 510k substantial equivalence determination with the FDA.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, manufacturers must provide detailed information about the new device and compare it to a predicate device to demonstrate substantial equivalence.

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 predicate device, thus allowing for faster market clearance.

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

Manufacturers must report detailed technical information about the new device, its intended use, components, performance characteristics, and any differences from the predicate device.