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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k170232 B. Purpose for Submission: New device C. Measured: Thyroid stimulating

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Here is how to fill out 510k substantial equivalence determination:
2. Begin by completing the 510(k) Substantial Equivalence Determination Form.
3. Provide the necessary information about the medical device in question.
4. Clearly state the intended use of the device and its technological characteristics.
5. Include any supporting documentation or evidence that demonstrates the device's substantial equivalence to a predicate device.
6. Submit the completed form and supporting documents to the appropriate regulatory authority for review and approval.
7. Await a determination from the regulatory authority regarding the substantial equivalence of the device.
8. If necessary, address any additional requests or inquiries from the regulatory authority to ensure a thorough evaluation.
9. Upon receiving approval, the device can proceed with the necessary regulatory processes for market entry.
10. Note: It is important to consult with regulatory experts or legal advisors to ensure accurate and compliant completion of the 510k substantial equivalence determination.

Who needs 510k substantial equivalence determination?

1. Anyone who intends to market a medical device that requires clearance or approval from regulatory authorities needs to undergo the 510k substantial equivalence determination process.
2. This determination is typically necessary for manufacturers, importers, or distributors of medical devices.
3. It ensures that the device being introduced to the market is safe and effective, and that it is equivalent in terms of intended use, technological characteristics, and performance to a legally marketed device known as a predicate device.
4. Therefore, anyone seeking to gain market access for a new medical device in the United States, under the 510k regulatory pathway, needs to undergo the substantial equivalence determination.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a regulatory process by which the FDA assesses whether a medical device is substantially equivalent to a legally marketed device that is not subject to premarket approval. It involves a comparison of the device's intended use, technological characteristics, and performance.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that wish to market a new device that is not exempt from premarket notification and is intended for the same use as a device already cleared by the FDA must file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

Filling out a 510(k) requires submitting a detailed application that includes information about the device, its intended use, technological characteristics, and clinical data if applicable, along with a comparison to the predicate device.

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 demonstrating that they are equivalent to existing devices that are already on the market.

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

The 510(k) submission must report details including device description, intended use, labeling, summary of non-clinical and clinical data, and comparison with the predicate device regarding safety and effectiveness.