What Are the Steps of the 510(k)-submission Process?

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2024-04-30 08:53:11

People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is...

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