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ATT 18 Functional Requirements Document Chapter 2 Part I  Form

ATT 18 Functional Requirements Document Chapter 2 Part I Form

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in this module we'll discuss what defines a product as a medical device in the eyes of the FDA we'll also go over the importance of proper device classification before moving on to the different classifications and then finally how they're classified step one is device classification the way the FDA classifies your product lays the groundwork and determines the number and complexity of requirements of the rest of the process this page displays the official recognized definition directly from section 2 zero one H of the Federal Food Drug and Cosmetic Act as you can see it's very precise the short version a medical device is something used to diagnose cure treat mitigate or prevent a disease it is also used in restoring correcting or modifying a body function the United States divided two medical devices into three classifications class one two and three the classification depends on a number of factors including how similar it is to an existing device obv

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