The medical device amendments were written to the Federal Food Drug and Cosmetic Act in May 1976. All new medical devices, including lasers became subject to the FDA premarket clearance. The 1976 amendments established a three-tiered system of medical devices, which categorized the thousands of different types of marketed medical devices into three groups—based on the risk of injury associated with using the device.8 Relatively risk-free devices, such as tongue depressors, bandages, toothbrushes, and the like, were
Table 22.1 Center for Devices and Radiological Health Milestones15 (Continued)
placed in Class I, necessitating minimal government supervision and regulation over the manufacture and marketing of these devices. Devices associated with the most significant risks, for example, cardiac pacemakers, prosthetic cardiac valves, and so on, were placed in Class III with comprehensive and stringent regulations relating to the development, testing, manufacturing, and marketing of the devices. Class II devices encompassed those devices representing mild to moderate risks.
The 1976 amendments codified the following:
a. Required to demonstrate safety and effectiveness of medical devices
b. Medical device classification introduced three classes (I, II, III)
— Class-I: general controls9 are adequate for assuring safety and effectiveness
— Class-II: special controls10 needed
— Class-III: premarket approval is necessary to demonstrate safety and effectiveness
c. All device manufacturers are required to register with the FDA