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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k180356 B. Purpose for Submission: New Device C. Measured: Glucose, protein,

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 providing the necessary administrative information, including the applicant name, address, and contact details.
3. Identify the medical device for which you are seeking substantial equivalence determination, including its intended use and indications for use.
4. Provide a comprehensive description of the device, including its design specifications, materials, components, and accessories.
5. Include information on the technological characteristics of the device, such as its mechanism of action and performance standards.
6. Conduct a comparison between the subject device and the predicate device(s), highlighting the similarities and differences in terms of design, materials, performance, and intended use.
7. Submit any clinical or non-clinical testing data, laboratory analyses, or other supporting documentation to demonstrate the substantial equivalence of the subject device to the predicate device(s).
8. Include a summary of any relevant published literature or scientific studies that support the substantial equivalence claim.
9. Provide a comprehensive summary or risk analysis, including any potential hazards, device failures, or adverse events associated with the subject device.
10. Compile the necessary labeling information, such as instructions for use, warnings, precautions, and contraindications.
11. Finally, complete the necessary forms and documentation as required by the regulatory authorities, ensuring accuracy and completeness.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor who intends to market a medical device in the United States may need to obtain a 510k substantial equivalence determination.
2. This determination is especially crucial for medical devices that do not qualify for exemptions under the Federal Food, Drug, and Cosmetic Act.
3. The requirement applies to both new devices entering the market and modifications to existing devices that may affect their safety or performance.
4. Ultimately, it is the responsibility of the manufacturer or distributor to assess whether their device falls under the regulations and requirements for 510k approval.

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What is 510k substantial equivalence determination?

510(k) substantial equivalence determination is a premarket submission made to the FDA to demonstrate that 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 introducing a new device to the market or making significant modifications to an existing device are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

The process of filling out a 510(k) substantial equivalence determination involves providing detailed information about the new device, its intended use, performance characteristics, and how it compares to a legally marketed predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510(k) substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed device, allowing for expedited approval by the FDA.

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

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