How are Class III medical devices characterized in terms of risk?

Class III medical devices are characterized by a high level of risk. They are typically those that are used to sustain or support life, are implanted in the body, or present a potential unreasonable risk of illness or injury. Due to these factors, Class III devices require stringent regulatory controls and must undergo the most rigorous pre-market approval processes by the FDA. This classification includes devices such as pacemakers and implanted prosthetics.

In contrast, Class I and Class II devices present lower risks and have different regulatory pathways. Class I devices are subject to general controls and typically do not require pre-market approval, while Class II devices may require special controls but do not reach the same level of scrutiny as Class III devices. Understanding these classifications helps in comprehending the regulatory environment and risk management practices essential in the healthcare industry.