Medical devices can be classified based on required level of control to ensure safety and effectiveness of the device. As this is risk-based classification, the major class determination factor is the risk the device poses to the patient or the user. According to FDA, Medical devices can be classified into three classes: Class I (General controls), Class II (General controls with special controls) and Class III (General controls, Special Controls and premarket approval) devices.
- Class I: These devices are subject to general control and need the least regulatory control. This class of devices have the lowest level of risks. Class I devices are not planned to help, support or sustain life and may not present any irrational risks of illness or injury to the user. Most of these devices do not need premarket notification and some exempt to follow manufacturing practice regulation. Examples: bandages, hand-held surgical instrument, examination gloves, etc.
- Class II: These devices are subject to special controls, in additional to general control. Special controls are device specific regulatory controls that ensure that the devices meet the intended functionality. The devices for which general control alone cannot assure safety and effectiveness, will require additive control similar to that of the existing approved devices. Few of these devices are exempted from premarket notification and requires special labeling, performance standards, and post market observation as special controls. Examples: acupuncture needles, powered wheelchairs, infusion pumps, pregnancy kits, and surgical drapes, etc.
- Class III: Devices for which even special controls in addition to general control cannot provide sufficient assurance for safety and effectiveness, and which needs premarket approval for a review concerning safety and effectiveness will fall under this class. The aim of these devices are to support and sustain human life functions.
