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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k182874 B. Purpose for Submission: New Device C. Measured: Breath Nitric Oxide D.

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out the 510k substantial equivalence determination, follow these steps:
2. Gather all necessary information and documentation about the medical device intended for submission.
3. Review the FDA guidance documents regarding substantial equivalence determination for 510k submissions.
4. Identify the predicate device that will serve as a comparison for substantial equivalence.
5. Compare the device to the predicate device and evaluate their similarities and differences.
6. Prepare a written report summarizing the comparison and determination of substantial equivalence.
7. Complete the 510k submission form accurately and thoroughly, providing all required information and supporting documents.
8. Include any additional information or data that may be requested by the FDA reviewer.
9. Submit the filled-out 510k substantial equivalence determination to the FDA for review and approval.
10. Respond promptly to any requests for additional information or clarification from the FDA.
11. Upon receiving FDA clearance, ensure that all labeling and promotional materials comply with the approved substantial equivalence determination.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor of a medical device in the United States that does not qualify for exempt status requires a 510k substantial equivalence determination.
2. This determination is necessary for devices that have the same intended use as a legally marketed predicate device but have different technological characteristics or make different claims of safety and effectiveness.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process by which the FDA evaluates whether a medical device is substantially equivalent to a legally marketed device. This determines if the new device can be marketed without the need for clinical trials.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who intend to market a device that is not exempt from premarket notification are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k), manufacturers must submit a premarket notification to the FDA, which includes detailed information about the device, comparative analysis with a predicate device, and evidence supporting substantial equivalence.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to ensure that new medical devices are safe and effective by comparing them to similar, previously cleared devices, thereby facilitating quicker access to essential medical products.

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

Information that must be reported includes the device description, intended use, information on the predicate device, performance data, labeling, and any unique features of the new device.