What is the difference between Class I, II, and III medical devices?

The classification of medical devices into Class I, II, and III is based on the level of risk they pose to patients and the required regulatory controls to ensure their safety and effectiveness.

Class I devices are indeed categorized as low-risk, such as bandages and examination gloves, and are subject to the least regulatory control. They typically do not require premarket approval; however, they must adhere to general controls and regulations.

Class II devices are considered moderate-risk, requiring more regulatory controls to provide assurance of their safety and effectiveness. These often require submission of a 510(k) application, demonstrating that the device is substantially equivalent to a device already on the market.

Class III devices are classified as high-risk and typically require premarket approval (PMA) due to their significant risk of harm to the user. Examples of Class III devices include pacemakers and implantable defibrillators. This rigorous approval process involves extensive clinical testing to ensure the device's safety and efficacy.

This classification system is crucial in the medical device industry, guiding manufacturers on the necessary regulatory pathways for their products and ensuring that patients receive safe and effective medical technologies.