What Is FDA 510K?

Section 510(k) of the Food, Drug and Cosmetic Act states that medical device manufacturers must inform the U.S. Food and Drug Administration (FDA) at least 90 days before they plan to market a medical device. This requirement is sometimes called premarket notification.

Purpose

• Section 510(k) helps the FDA make sure new medical devices are safe and effective. New medical devices submitted under 510(k) rules must also be "substantially equivalent" to an existing legally marketed device, which is referred to as the "predicate."

Features

• Substantial equivalence does not mean that two products are identical. However, the new product should have the same intended use and be as safe and effective as the predicate.

Function

• Manufacturers cannot market their new medical device until the FDA responds to the 510(k) application with a letter that gives permission to market the new device in the U.S.