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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k171941 B. Purpose for Submission: Expansion of the indications for use of Freestyle

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Step 1: Gather all the necessary information and documentation regarding the device for which the substantial equivalence determination is sought.
2. Step 2: Determine the appropriate FDA classification for the device.
3. Step 3: Prepare a well-organized and detailed 510(k) submission, including a cover letter, device description, intended use statement, comparison to a predicate device, performance data, and other required information.
4. Step 4: Submit the 510(k) application electronically through the FDA's electronic submission gateway.
5. Step 5: Pay the required user fee for the 510(k) submission.
6. Step 6: Await FDA review and response. It may take several months for the FDA to review the submission and provide a determination.

Who needs 510k substantial equivalence determination?

1. Manufacturers who wish to introduce a new medical device to the US market that is not exempt from premarket notification requirements.
2. Manufacturers who have made modifications to an existing medical device that could significantly affect its safety or effectiveness.
3. Manufacturers of certain types of in vitro diagnostic devices that are subject to premarket notification requirements.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process conducted by the FDA to evaluate whether 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 are required to file a 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, manufacturers must provide detailed information about the new device and explain how it is similar to and different from the predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to ensure that new medical devices are safe and effective by comparing them to devices that are already on the market.

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

Information such as device description, intended use, indications for use, materials, design, performance data, and labeling must be reported on a 510k substantial equivalence determination.