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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:

1. Class I Medical Devices:

   • These devices are low-risk and generally pose minimal potential harm to the user.
   • Examples include elastic bandages, non-powered wheelchairs, and exam gloves.
   • Class I devices are subject to general controls, such as labeling requirements and adherence to Good Manufacturing Practices (GMP). Most are exempt from premarket notification requirements (510(k)).

2. Class II Medical Devices:

   • Class II devices are moderate-risk devices that require special controls to provide reasonable assurance of safety and effectiveness.
   • Examples include powered wheelchairs, infusion pumps, and surgical drapes.
   • Manufacturers must submit a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device, unless exempted.

3. Class III Medical Devices:

   • These devices are high-risk and typically support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
   • Examples include implantable pacemakers, heart valves, and HIV diagnostic tests.
   • Class III devices require premarket approval (PMA) based on scientific evidence, including clinical data demonstrating safety and effectiveness.

Classification Process:

• Classification Determination: Manufacturers are responsible for determining the appropriate classification of their devices based on intended use, technological characteristics, and potential risks.

• FDA Review: The FDA reviews and assigns the final device classification based on the manufacturer's submission and supporting data.

• Regulatory Requirements: Each device class is subject to specific regulatory requirements, including labeling, manufacturing controls, and post-market surveillance, to ensure ongoing safety and effectiveness.

This classification system ensures that medical devices in the U.S. market are appropriately regulated according to their risk profile, balancing patient safety with timely access to innovative technologies.