What is the primary purpose of a traditional 510(k) submission?

The primary purpose of a traditional 510(k) submission is to seek marketing clearance for a device that is substantially equivalent to a device that is already legally marketed in the United States. By demonstrating substantial equivalence, the manufacturer is asserting that their new device is similar in intended use and technology to a predicate device. This process allows for a faster pathway to market compared to other regulatory pathways, like premarket approval, which requires more extensive evidence of safety and efficacy.

The focus of the 510(k) process is to ensure that the new device does not pose any additional risks compared to the predicate device, thereby streamlining the approval process while maintaining patient safety. This is a critical mechanism that supports innovation while ensuring that new medical devices can enter the market efficiently.