What is a Class III Device?

Class III Device Definition

The Food and Drug Administration (FDA) classifies medical devices into three main categories. Each device is assigned to one of three regulatory classes based on the level of control required to ensure the safety and effectiveness of a device.

Class III medical devices have a high risk to patients or users. These devices help sustain or support life, can be implanted, and/or present potential unreasonable risk of illness or injury. They represent about 10% of medical devices and some examples include defibrillators, pacemakers, breast implants, and implanted prosthetics.

Class Three Device Diagram

FAQs

Do class 3 devices need a 510(k)?

Class 3 content is being added. Stay tuned.

What's the difference between a class 3 and class 1 medical device?

Class 3 content is being added. Stay tuned.

What's the difference between a class 3 and class 2 medical device?

Class 3 content is being added. Stay tuned.

How do I know if a device has been FDA-approved?

Class 3 content is being added. Stay tuned.

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