FDA 510(k) Clearance and Premarket Approval for USA

The FDA 510(k) is a regulatory submission required by the U.S. Food and Drug Administration (FDA) for most medical devices intended for commercial distribution in the United States. The 510(k) process is used to demonstrate the substantial equivalence of a new medical device to a legally marketed predicate device. By showing that the new device is similar in intended use, technological characteristics, and performance to the predicate device, the manufacturer seeks clearance to market and sell the device. The FDA reviews the 510(k) submission to evaluate the safety and effectiveness of the device before granting clearance.