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

A 510(k) submission serves the specific purpose of demonstrating substantial equivalence to a legally marketed device. This pathway allows manufacturers to seek FDA clearance for medical devices by showing that their product is as safe and effective as an existing one that is already on the market.

The 510(k) process is a key component of the premarket requirements for devices that are not classified as high-risk. When a company submits a 510(k), they must provide data that supports their claim of substantial equivalence, typically including information about the device's design, intended use, and performance characteristics compared to the predicate device.

This pathway helps facilitate the entry of medical devices into the market while ensuring that they meet the FDA's safety and efficacy standards based on established benchmarks from similar devices. By focusing on substantial equivalence, the 510(k) process helps streamline regulatory oversight and encourages innovation while protecting public health.