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)?

A majority of Class II devices require a 510(k) premarket notification.

*Source: https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-ii-exemptions

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

Class II medical devices pose a moderate to high risk to patients and/or intended users, whereas Class I devices pose a low to moderate risk.

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

Class II medical devices pose a moderate to high risk to patients and/or intended users and require a premarket 510(k) submission, whereas Class III devices pose a high risk and require more extensive clinical evidence in the form of a premarket approval (PMA).

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

To determine if a device has been cleared or approved by the FDA, check the FDA 510(k) Premarket Notification database or the FDA Premarket Approval (PMA) database.

*Source: https://www.fda.gov

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