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Class I 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 I devices have a low to moderate risk to patients or users. Almost half of medical devices are classified as Class I and over 90% of these are exempt from the regulatory process. Class I devices do not require premarket notification (510k) applications and FDA clearance is also not required before selling the device in the United States. Examples of Class I devices include bandages, disposable gloves, tongue depressors, medical thermometers, and stethoscopes.

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External Resources

• Classify Your Medical Device
• Overview of Device Regulation
• Premarket Notification 510(k)
• Device Regulation & Classification
• Product Classification