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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k101037 B. Purpose for Submission: New device C. Measured: Whole blood glucose D.

How to fill out 1 510k substantial equivalence

How to fill out 1 510k substantial equivalence

1. Step 1: Gather all necessary information and documents. This includes information about the medical device, its intended use, its components, and its manufacturing process.
2. Step 2: Prepare a detailed description of the medical device, including its design, performance characteristics, and labeling.
3. Step 3: Conduct a thorough analysis to assess the substantial equivalence of the medical device to a predicate device that has already been cleared by the FDA.
4. Step 4: Prepare a written submission, known as a 510(k) application, which includes all the necessary information, such as detailed descriptions, test results, and labeling information.
5. Step 5: Submit the 510(k) application to the FDA and pay the appropriate fees.
6. Step 6: Cooperate with the FDA during the review process, including providing additional information or clarifications if requested.
7. Step 7: Await the FDA's decision on the substantial equivalence of the medical device. This decision will determine whether the device can be marketed in the United States.

Who needs 1 510k substantial equivalence?

1. Manufacturers of medical devices who intend to introduce a new device into the U.S. market.
2. Manufacturers of medical devices who have made changes or modifications to an already cleared device.
3. Manufacturers of medical devices who want to demonstrate that their device is substantially equivalent to a predicate device in order to avoid the need for conducting full clinical studies.

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What is 1 510k substantial equivalence?

510(k) substantial equivalence is a premarket submission made to FDA to demonstrate that a new medical device is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file 1 510k substantial equivalence?

Medical device manufacturers who intend to market a new medical device in the United States are required to file a 510(k) substantial equivalence.

How to fill out 1 510k substantial equivalence?

To fill out a 510(k) substantial equivalence, manufacturers need to provide detailed information comparing the device to a predicate device, including performance data and descriptions of similarities and differences.

What is the purpose of 1 510k substantial equivalence?

The purpose of a 510(k) substantial equivalence is to demonstrate that the new device is as safe and effective as a legally marketed device and therefore can be marketed in the US.

What information must be reported on 1 510k substantial equivalence?

Information reported on a 510(k) substantial equivalence includes device descriptions, performance data, proposed labeling, and comparison to predicate device.