FDA (510k) filing

An [http://www.fda.gov/cdrh/devadvice/314.html FDA (510)k] filing is a premarket submission made to the U.S. Food and Drug Administration to demonstrate that a medical device to be marketed is "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."

The concept of "substantially equivalent" (or "SE" in FDA nomenclature), has implications for public safety and for the ability of a manufacture to commercialize a product, because "Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S."