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    Food and Drug Administration (FDA) Medical Device Classes

    The Food and Drug Administration (FDA) medical device classes are part of a three-tiered classification system that outlines the levels of control necessary for medical devices.

    What Are Food and Drug Administration (FDA) Medical Device Classes?

    As part of its overall mission to ensure the health and safety of food and medical items, the FDA established a three-tiered system for identifying the risks and regulatory controls associated with particular medical devices: Food and Drug Administration (FDA) medical device classes. Devices include pacemakers, stents, surgical trays, diagnostic tests, and thousands of others.

    The Food and Drug Administration (FDA) medical device classes include — Class I, II, or III. These class labels are posted on medical devices to indicate the level of patient risk each product or device holds,  based on the intended use of the device, with Class I posing the lowest risk.

    To sell medical devices, manufacturers must classify their devices within the FDA’s system using FDA criteria. For items that manufacturers can sell to the general public (those without a medical license, for example), noting the classification with the product’s description is critical, as it can help consumers make the most informed purchasing decision.

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