In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.

The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class III, with Class III medical devices as the highest risk class.

The FDA defines a Class III medical device as “one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury.”

Given the significant risk inherent in Class III devices, and the often critical nature of their role in medicine, Class III devices are subject to the most stringent regulatory controls. Here, I’ll cover device classification, regulatory pathways, and more for Class III medical devices. 

How does FDA categorize Class III medical devices?

The FDA assigns a device to a risk class based on the level of regulatory controls required to ensure that the device is safe and effective.

Class I medical devices (low to moderate risk) are subject to general controls.

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