Class II medical devices are those for which general controls alone cannot assure safety and effectiveness. The potential risk of using these devices is higher.

Class II medical devices include many diagnostic instruments who misuse, failure, or absence with no replacement available would have a significant impact on patient care, but wouldn’t directly cause serious injury.

In addition to complying with general controls, Class II medical devices are also subject to special controls. Special controls are device specific and include such things as special labeling requirements, mandatory performance standards, and post market surveillance.

Most Class II medical devices must receive clearance from the FDA before they can be sold in the United States. The clearance process is known as premarket notification. The FDA is able to proactively ensure safety and efficacy of Class II medical devices before they are placed on the market.

Examples of Class II medical devices:

- powered wheelchair
- infusion pump
- hearing aid
- surgical drill
- ultrasound
- short-term implant

Learning Objectives:

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