Medical devices include an array of aids and instruments used in the prevention, diagnosis and treatment of a disease or condition. They range from the lowly tongue depressor to the programmable pacemaker. Although the FDA regulates medical devices, they are often approved quickly and inappropriately. As a result, dangerous and even deadly devices enter the market.
Public Citizen has fought to insure that medical devices are properly classified and therefore subjected to adequate regulation. We have also been involved with post-marketing studies, which are designed to insure that devices are safe when used by a larger population in a variety of settings.