The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.

Abstract

The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices. The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were r