US FDA Medical Device Classification 

US FDA Medical Device Classification

Class I

These are low-risk devices that are subject to the least regulatory control. They are typically simple in design and pose minimal risk to patients.

Examples include bandages, tongue depressors, and most non-powered surgical instruments. Most Class I devices are exempt from the premarket notification (510(k)) or premarket approval (PMA) requirements, but they still need to comply with general controls, such as good manufacturing practices (GMP) and labelling requirements. 

Class II

These are moderate-risk devices that are subject to special controls to provide reasonable assurance of safety and effectiveness. Special controls may include performance standards, post-market surveillance, patient registries, and FDA guidance documents.

Examples of Class II devices include powered wheelchairs, infusion pumps, and certain types of surgical gloves. Most Class II devices require a 510(k) premarket notification before they can be marketed, demonstrating that they are substantially equivalent to a legally marketed predicate device. 

Class III

These are high-risk devices that are subject to the highest level of regulatory control. They are usually intended to support or sustain life, are implanted into the body, or present potential unreasonable risk of illness or injury.

Examples include implantable pacemakers, heart valves, and deep brain stimulators. Class III devices typically require premarket approval (PMA) from the FDA, which involves a comprehensive review of scientific evidence to demonstrate safety and effectiveness. 

In addition to these main classes, certain types of medical devices may be classified as “de novo” if they do not have a legally marketed predicate device and do not meet the criteria for automatic Class I or Class II classification. The FDA’s device classification system helps ensure that medical devices are appropriately regulated to protect public health while allowing timely access to innovative technologies. It provides a framework for manufacturers to understand the regulatory requirements applicable to their devices and helps healthcare providers and patients make informed decisions about the use of medical devices.