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In the United States, medical devices are classified into three main categories based on the level of risk they pose to patients and the regulatory controls necessary to ensure their safety and effectiveness. These three classes are:

1. Class I (Low Risk):

   • These devices present the lowest risk to patients and are subject to the least regulatory control.
   • Most Class I devices are exempt from premarket notification (510(k)) and do not require premarket approval (PMA).
   • Examples: Bandages, handheld surgical instruments, and certain dental devices.

2. Class II (Moderate Risk):

   • These devices present a moderate risk to patients and require more regulatory controls to ensure their safety and effectiveness.
   • Class II devices typically require 510(k) clearance (premarket notification), which means the manufacturer must demonstrate that the device is substantially equivalent to an already marketed device.
   • Examples: Infusion pumps, contact lenses, and powered wheelchairs.

3. Class III (High Risk):

   • These devices pose the highest risk to patients and are subject to the most stringent regulatory controls.
   • Class III devices typically require Premarket Approval (PMA), a more rigorous and comprehensive process that includes clinical trials to demonstrate safety and effectiveness.
   • Examples: Pacemakers, heart valves, and certain types of surgical implants.

These classifications help the FDA (Food and Drug Administration) determine the regulatory requirements for each device, balancing the need for patient safety with the necessity for market access.

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