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In Depth: The US FDA 510(k) Clearance Process

You've done the hard work of classifying your product in the US - now it's time to get FDA clearance and start selling your device. But to sell a class 2 medical device in the US, you must submit a 510(k) to the US FDA. Knowing what to expect from this process can save you time, money, and some unnecessary headaches.

This short video provides an overview of the steps required to get your class II medical device cleared by the US FDA. From testing requirements to preparing your submission, this brief tutorial provides pertinent information on the 510(k) process and how to navigate it efficiently.