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    FDA Medical Device Classes

    The Food and Drug Administration (FDA) has established a three-tiered classification system for different medical devices. Each device is assigned to either Class I, II, or III.

    What are the medical device classes?

    The Food and Drug Administration (FDA) has established a three-tiered classification system for different medical devices. Each device is assigned to either Class I, II, or III.

     In ascending order, the medical device classes determine the necessary levels of control. Classification is based on the risk it presents to the patient and user. Each class assures the safety and effectiveness of the device during its intended use.

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