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- Classification is determined by comparing a device to legally marketed devices and evaluating factors like intended use, technology, and potential risks. Regulatory requirements vary by class and include labeling, manufacturing standards, and post-market surveillance to maintain safety standards throughout the device's lifecycle.
- In the United States, medical devices are classified into three main categories based on the level of risk associated with their use and the regulatory controls necessary to ensure their safety and effectiveness:
- In the United States, medical devices are classified based on their level of risk and intended use. The classification system, established by the Food and Drug Administration (FDA), ensures that appropriate regulatory controls are applied to each category of device to provide reasonable assurance of its safety and effectiveness. Here’s a detailed explanation of how medical devices are classified in the U.S.:
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