FDA 510(k) Process

The FDA 510(k) process is a pathway for medical device manufacturers to demonstrate that their device is safe and effective by showing it is substantially equivalent to an already approved device. This means the new device is similar in intended use, technology, and performance to one that's on the market. By submitting a 510(k) application, companies provide data to prove safety and effectiveness without undergoing the more extensive premarket approval process. If the FDA accepts the application, the device can be legally marketed in the U.S., facilitating quicker access to innovative medical technologies for patients.