ABSTRACT
Another milestone came with the Medical Devices Act of 1990, which was primarily concerned with user and manufacturer medical device reporting and with post-marketing surveillance and tracking for safety. 5
The FDA ’ s Center for Devices and Radiological Health has primary responsibility for regulating medical devices. As noted above, the Center divides these into three classes (the higher the class, the higher the risk): 7,8
■ class I – those devices that do not support human life, and are not important in preventing impairment of human health, and do not pose significant risk of illness or injury. Examples would include dental filling, daily-wear contact lenses, and tongue depressors. These devices are regulated by ‘general controls ’ , which are primarily post-marketing and meant to ensure safety, purity, and accurate labeling.
