Class III medical devices are high-risk devices. They support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.

Class III medical devices must undergo a more exacting and expensive process before they can be sold in the United States, typically requiring clinical trials. This process is known as premarket approval or PMA. This process allows the FDA to thoroughly evaluate the device before they are sold.

Examples of Class III medical devices:

- implantable pacemaker
- pulse generator
- cardiac stent
- automated external defibrillator
- neuro-endoscope
- long-term implant

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.