Overview of the FDA 510(k) Process

Many companies who plan to introduce a device to the US market need to submit an application to the FDA called a 510(k). The 510(k) is needed for some Class I devices, nearly all Class II devices and a very small assortment of Class III devices. The diagram below shows an overview of how the FDA 510(k) process works. Learn more about how Emergo Group can help prepare and submit your FDA 510(k) application.

Read more about your obligations to meet FDA Good Manufacturing Practice (GMP).