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How are medical devices classified in the United States?
Category：企业动态 Date：2024-12-25 17:23:22 Author: Source:
In the United States, medical devices are classified into three categories based on their risk level and the level of regulatory control required by the FDA. These classifications are:

In the United States, medical devices are classified into three categories based on their risk level and the level of regulatory control required by the FDA. These classifications are:

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  1. Class I:

    • Low risk devices that generally do not require premarket approval.
    • Most Class I devices are exempt from premarket notification (510(k)) and only need to comply with general controls, such as labeling requirements and good manufacturing practices (GMP).
    • Examples: Bandages, stethoscopes, tongue depressors.

  2. Class II:

    • Moderate risk devices that require premarket notification through the 510(k) process, where manufacturers demonstrate that the device is substantially equivalent to a legally marketed device.
    • Class II devices must meet specific performance standards and post-market surveillance requirements.
    • Examples: Infusion pumps, blood pressure cuffs, surgical drapes.

  3. Class III:

    • High risk devices that require Premarket Approval (PMA), a more rigorous process that includes clinical trials and comprehensive data to demonstrate the device's safety and efficacy.
    • Class III devices are typically life-supporting or life-sustaining, or they present a significant risk of injury or illness.
    • Examples: Pacemakers, artificial heart valves, neurostimulators.

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