FDA 510(k)

The FDA 510(k) is a notification that medical device manufacturers submit to demonstrate their device is substantially equivalent to an already legally marketed device. This process is required before selling certain medical devices in the U.S. to ensure safety and effectiveness. Manufacturers compare their device’s design, materials, and function to existing approved devices, providing data to support their claims. If approved, the device can be marketed. The 510(k) process helps the FDA monitor and regulate medical devices, ensuring they meet safety standards without unnecessary delays in bringing new devices to market.