Overview of the USA FDA Classification Process

Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies devices and the tools available to you is critical for identifying the proper regulatory pathway in the United States. Choosing the wrong device class could cost you considerable time and money, and result in regulatory or legal actions.

In this short video we cover the classes of medical devices, provide examples of navigating the classification database, discuss Product Codes and Regulation Numbers, and provide useful tips to consider as you research your device.

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