510(k) Premarket Notification

A 510(k) Premarket Notification is a process that medical device companies use to get approval from the U.S. Food and Drug Administration (FDA) before selling certain medical devices. They must demonstrate that their device is as safe and effective as an existing, legally marketed device (called a "predicate"). This process helps ensure the device meets necessary safety standards without requiring extensive testing like new, innovative devices. It’s a key step for manufacturers to legally introduce devices into the U.S. healthcare market, promoting safety and innovation while facilitating timely access to medical technology.