Arthur K. Yellin, M.S., R.Ph.

There are two major processes by which medical devices requiring U.S. Food and Drug Administration (FDA) review come to the American market. One process is called “Premarket Notification,” sometimes referenced by its origins in the Federal Food, Drug and Cosmetic Act as the “510(k) process.” The other major process is called Premarket Approval and is known by its submission acronym “PMA.” This article describes and explains both processes. Premarket Notification: The 510(k) Process Contrary to popular belief, “510(k)” is not a form. It is actually a section of the Federal Food, Drug and Cosmetic Act (FD&CA, the Act) from which this process was circuitously derived. The process is somewhat analogous to the “generic” drug concept in that Premarket Notification is used to obtain marketing clearance …