What is a Premarket Notification (510k)?

Premarket Notification (510k) Definition

Premarket notification (510k or PMN) refers to premarket submission made to the FDA to demonstrate that a device can be marketed as safe and effective. Medical device manufacturers must register to notify the FDA per section 510(k) of the Federal Drug, and Cosmetic Act at least 90 days in advance of their intent to market a medical device.