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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.
A majority of Class I devices are exempt from a 510(k) premarket notification.
*Source: https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-ii-exemptions
Class I medical devices pose a low to moderate risk to patients and/or intended users, whereas Class II devices pose a moderate to high risk.
Class I medical devices pose a low to moderate risk to patients and/or intended users, whereas Class III devices pose a high risk. Premarket approval (PMA), which involves extensive clinical evidence, is required for Class III devices to prove their safety and efficacy.
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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