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U.S. Department of Health and Human Services

For Industry

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How can I find out how FDA will classify my device?

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are two methods for accomplishing this: go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation.

For more information on classification, please visit the Device Advice website.

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