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of all the steps in the US FDA medical device approval process classification is arguably one of the most important 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 interested in learning more about the US FDA classification process well show you [Music] you might ask yourself why is classification so important knowing if your device is class 1 2 or 3 determines the correct regulatory pathway to market the device ultimately choosing the wrong device class could cost you considerable time and money and potentially result in regulatory or legal actions when it comes to medical device classification different markets employ different systems some markets use a predicate based system wherein devices inherit the risk class of similar devices already for sale markets such as Europe and Canada follow a distinct set of logical rules to determine device classification still other marke
