An overview of the FDA 510(k) approval process

Many companies who plan to introduce a new 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 what is required for the FDA 510k process or how Emergo Group can help prepare and submit your FDA 510(k).

 Learn more about FDA 510k submissions on our dedicated website

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