- Contact
-
- North America
- EMEA
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.
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
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.
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).
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
Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.
