I haven't read the full paper yet, but here's an excerpt from the opening:
The United States has long been the home to cutting-edge innovations in the medical device industry, a remarkable private enterprise success that has improved or extended the lives of millions of people. However, increasingly burdensome regulatory policy is driving pioneering research and development to Europe and to the rest of the world. Nevertheless, the U.S. Food and Drug Administration (FDA) and self-styled public health advocates are engaged in an assault on the primary regulatory pathway through which new products reach the market. This could lead to further erosion of U.S. leadership in this important field.You can read the full paper here (PDF format).