In 1976, following reports that thousands of women had been harmed by using an intrauterine device for contraception, Congress responded by enacting the Medical Device Amendments, which authorized the FDA to classify all medical devices.
The three regulatory classes are based on the level of control necessary to assure the safety and effectiveness of the device. Device classification also depends on the intended use of the device and upon indications for use. And, classification is based on the risk the device poses to the patient and/or the user. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.
The initial FDA Medical Device Program began with a staff of about 180 people. Today, its Center for Devices and Radiological Health employs 1,700 individuals with a wide range of scientific, clinical, engineering, legal, and other expertise.
