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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: K162274 B. Purpose for Submission: To obtain a substantial equivalence determination

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Step 1: Begin by accessing the FDA's 510(k) substantial equivalence determination form.
2. Step 2: Provide the necessary information about the medical device you are seeking approval for.
3. Step 3: Clearly describe the intended use of the device and its technological characteristics.
4. Step 4: Identify the predicate device or devices to which your device is claimed to be substantially equivalent.
5. Step 5: Include any performance data, labeling, or other information that demonstrates the substantial equivalence of your device.
6. Step 6: Prepare a summary of the scientific and technical information supporting your substantial equivalence determination.
7. Step 7: Submit the completed form and all relevant supporting documents to the FDA for review.

Who needs 510k substantial equivalence determination?

1. Manufacturers or distributors of medical devices who wish to market a new device that is not exempt from 510(k) requirements.
2. Manufacturers or distributors of modified medical devices that may have significant changes in design, materials, or intended use compared to their predicate device.
3. Manufacturers or distributors of medical devices that have been classified by the FDA as requiring a 510(k) submission.

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What is 510k substantial equivalence determination?

510(k) substantial equivalence determination is a process by which the FDA evaluates whether a new medical device is as safe and effective as a legally marketed device, known as a predicate.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that are not exempt and wish to market their devices in the USA are required to file a 510(k) to demonstrate substantial equivalence to an existing approved device.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k), manufacturers must provide detailed information about the device, including its intended use, technological characteristics, and claimed substantial equivalence, along with any necessary supporting data and 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 comparable to existing devices in terms of safety and effectiveness prior to receiving market clearance from the FDA.

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

Information that must be reported includes device name, manufacturer details, intended use, descriptions of the device and its components, labeling, substantial equivalence claims, and relevant supporting data.