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What Are the Categories of Medical Device Classification in the United States?
Category：企业动态 Date：2024-11-20 17:05:37 Author: Source:
These categories help the FDA determine the level of regulatory control required for each device to ensure safety and effectiveness before it can be marketed in the U.S.

In the United States, medical devices are classified into three categories based on the level of risk they pose to patients and the regulatory requirements needed for approval. These categories are:

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  1. Class I (Low Risk):

    • Characteristics: Devices with the lowest risk, subject to general controls.
    • Examples: Bandages, handheld surgical instruments, and dental devices.

  2. Class II (Moderate Risk):

    • Characteristics: Devices that pose moderate risk, typically requiring more regulatory controls, such as 510(k) clearance.
    • Examples: Infusion pumps, pregnancy test kits, and powered wheelchairs.

  3. Class III (High Risk):

    • Characteristics: Devices with the highest risk, often sustaining or supporting life, and requiring Premarket Approval (PMA).
    • Examples: Pacemakers, heart valves, and certain implants.

These categories help the FDA determine the level of regulatory control required for each device to ensure safety and effectiveness before it can be marketed in the U.S.

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