A 510(k) is a premarket submission made by medical device manufacturers to the US Food and Drug Administration (FDA) that demonstrates the device is safe and effective. It is named after section 510(k) of the Federal Food, Drug, and Cosmetic Act, which requires device manufacturers to submit this form to the FDA before marketing any medical device.
When submitting a 510(k), the manufacturer must provide evidence that the device is substantially equivalent to a legally marketed device (predicate device) that is already available for sale in the U.S. The FDA then reviews the submission to determine whether the device is safe and effective for its intended use.
The 510(k) clearance process is generally quicker and less expensive than the Premarket Approval (PMA) process, which is required for devices that are not substantially equivalent to any legally marketed devices.
However, a 510(k) clearance does not guarantee the safety or efficacy of a device, and the FDA may order a device to be removed from the market if safety concerns arise after it has been cleared through 510(k).
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