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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k173638 B. Purpose for Submission: New device C. Measured: Fresh capillary whole

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 gathering all the necessary information and documentation related to the medical device.
3. Review the FDA classification and regulatory requirements for the device.
4. Identify the predicate device(s) that the new device will be compared to for determining substantial equivalence.
5. Prepare a detailed summary of the technological similarities and differences between the new device and the predicate device(s).
6. Provide documented evidence to support the substantial equivalence claim.
7. Complete the appropriate FDA forms and submit them along with all the required information and documentation.
8. Pay the necessary user fees for the 510k submission.
9. Await feedback from the FDA regarding the substantial equivalence determination.
10. Address any additional information or clarification requests from the FDA.
11. If the determination is successful, proceed with the necessary steps for marketing and distributing the medical device.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor of a medical device seeking to market and distribute their product in the United States generally needs a 510k substantial equivalence determination.
2. This requirement applies to both new devices and modifications to existing devices that may impact their safety and effectiveness.
3. It is important to note that certain exemptions or alternative pathways may exist for specific types of devices or situations.
4. It is advisable to consult with the FDA or seek legal guidance to determine if a 510k determination is necessary for a particular medical device.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process used by the FDA to assess whether a medical device is comparable to a previously cleared device, known as a predicate device, in terms of safety and effectiveness.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that intend to market a new device that is substantially equivalent to a predicate device under the FDA regulations are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) submission, a manufacturer must complete a premarket notification form that includes device descriptions, indications for use, performance testing data, and a comparison to the predicate device, along with any necessary supporting documentation.

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 shown to be safe and effective compared to existing products before they can be marketed.

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

The reported information includes device name, intended use, description of the device, labeling, summary of any performance tests conducted, and detailed comparisons with predicate devices.