What is a Class II Device?

Class II 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 II medical devices have moderate to higher risks to patients or users. Over 40% of medical devices fall into this device category. The majority of medical devices are considered to be Class II devices. Some examples of Class II devices include catheters, syringes, contact lens, and pregnancy test kits.

Class Two Device Diagram

FAQs

Do class 2 devices need a 510(k)?

Class 2 content is being added. Stay tuned.

What's the difference between a class 2 and class 1 medical device?

Class 2 content is being added. Stay tuned.

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

Class 2 content is being added. Stay tuned.

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

Class 2 content is being added. Stay tuned.

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