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The US FDA medical device approval process includes classification as a critical step. Understanding how devices are classified and the tools available is crucial for identifying the proper regulatory pathway in the United States. Knowing if your device is class 1, 2, or 3 is important as it determines the correct pathway to market. Choosing the wrong device class could result in significant time, money, and potential regulatory or legal issues. Different markets have different classification systems, such as predicate-based systems or logical rules in Europe and Canada.
