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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k111029 B. Purpose for Submission: New 510(k) for diabetes data management

How to fill out 510k substantial equivalence

How to fill out 510k substantial equivalence

1. Gather all necessary information and documentation for your medical device.
2. Determine the appropriate FDA guidance document for your device type.
3. Prepare a 510(k) submission in accordance with the FDA's requirements.
4. Complete the FDA Form 3514 to demonstrate substantial equivalence.
5. Include a detailed comparison of your device to a legally marketed predicate device, highlighting similarities and differences.
6. Provide scientific and technical data, including performance testing, to support your claim of substantial equivalence.
7. If necessary, conduct any additional testing or studies requested by the FDA.
8. Submit your completed 510(k) application to the FDA for review.
9. Cooperate with the FDA during the review process, responding to any requests for additional information or clarification.
10. Await a decision from the FDA regarding the substantial equivalence of your device.

Who needs 510k substantial equivalence?

1. Any manufacturer or distributor of a medical device that is subject to premarket notification requirements under the Federal Food, Drug, and Cosmetic Act needs to demonstrate 510(k) substantial equivalence.
2. This includes both new medical devices and modifications to existing devices that could significantly affect their safety or effectiveness.
3. The 510(k) submission is necessary to obtain FDA clearance for the device to be legally marketed in the United States.

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What is 510k substantial equivalence?

510k substantial equivalence is a process used by the FDA to determine if a new medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence?

Manufacturers of medical devices who are seeking FDA clearance to market a new device are required to file a 510k substantial equivalence.

How to fill out 510k substantial equivalence?

To fill out a 510k substantial equivalence, manufacturers must provide detailed information on the new device, compare it to a predicate device, and demonstrate that it is substantially equivalent.

What is the purpose of 510k substantial equivalence?

The purpose of 510k substantial equivalence is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device.

What information must be reported on 510k substantial equivalence?

Information such as device description, intended use, technical specifications, testing data, and comparison to predicate device must be reported on 510k substantial equivalence.