Regulatory Reticence and Medical Devices

In this issue of The Milbank Quarterly, the article “Improving Medical Device Regulation: The United States and Europe in Perspective,” by Corinna Sorenson and Michael Drummond, examines recent changes intended to improve the effectiveness of regulations for pre-and postmarket surveillance of medical devices in the United States and Europe. The authors deftly analyze the numerous weaknesses of current policies in both countries, urge that changes be implemented “in a timely manner,” and recommend further actions to enhance their effectiveness. They conclude that these relatively small changes in regulatory policy will make a substantial difference in the safety and quality of medical devices.1