Medical Device Regulation in the United States — An Overview
QU Bao-gang Center for Medical Device Evaluation, SFDA (Beijing 100044)
First, the paper presents a view of the administration organization of FDA, Explains two approaches (510(k) and PMA) that the medical device is marketed on U.S.A. emphatically. Then readers can know how is FDA control and supervise medical device factory to come through quality system. In the end of the paper, the concept of IDE( Investigational Device Exemption) application and substantial regulation which is post-market surveillance has also been provided.