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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 III medical devices have a high risk to patients or users. These devices help sustain or support life, can be implanted, and/or present potential unreasonable risk of illness or injury. They represent about 10% of medical devices and some examples include defibrillators, pacemakers, breast implants, and implanted prosthetics.
Class III devices do not require a 510(k) premarket notification; however, they do require a premarket approval (PMA) which involves extensive clinical evidence to prove their safety and efficacy.
*Source: https://www.fda.gov
Class III medical devices pose a high risk to patients and/or intended users, whereas Class I devices pose a low to moderate risk.
Class III devices pose a high risk to patients and/or intended users and require a premarket approval (PMA) to demonstrate safety and efficacy. Class II devices pose a moderate to high risk and require only a 510(k) premarket notification.
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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