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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k170064 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 a 510k substantial equivalence determination, follow these steps:
2. Begin by preparing the necessary documents and samples for submission.
3. Fill out the appropriate sections of the 510k form, including the general information section, device description, and proposed labeling.
4. Provide detailed information about the predicate device(s) that will be used for substantial equivalence comparison.
5. Include any supporting documentation or test reports that demonstrate the safety and effectiveness of the new device.
6. Ensure all required attachments, such as labeling, labeling samples, and instructions for use, are included.
7. Review the completed form and all supporting documents for accuracy and completeness.
8. Submit the 510k substantial equivalence determination to the appropriate regulatory authority for review and approval.
9. Follow up with the regulatory authority to address any additional requests or questions they may have.
10. Upon clearance, maintain proper documentation and ensure compliance with all applicable regulations.
11. Note: It is always recommended to consult with regulatory experts or legal professionals for specific guidance on filling out the 510k substantial equivalence determination.

Who needs 510k substantial equivalence determination?

1. Any medical device manufacturer planning to introduce a new medical device into the market that is subject to regulation by the US Food and Drug Administration (FDA) may need to obtain a 510k substantial equivalence determination.
2. Healthcare facilities and organizations that utilize medical devices may also need to be aware of the 510k substantial equivalence determination process to understand the regulatory status and compliance of the devices they purchase and use.
3. It is important to note that the specific requirement for a 510k determination may vary depending on the type and intended use of the medical device. Therefore, it is recommended to consult with regulatory experts or legal professionals for a thorough evaluation of the need for a 510k substantial equivalence determination.

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What is 510k substantial equivalence determination?

A 510k substantial equivalence determination is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Who is required to file 510k substantial equivalence determination?

Manufacturers of new medical devices that are not exempt from 510k requirements 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 medical device, its intended use, technological characteristics, and comparison to a predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of a 510k substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device, allowing it to be cleared for marketing by the FDA.

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

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