The FDA is forcing medical device companies to focus on OUS markets

Medical Device Makers Shun United States (NYTimes)

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the US and overseas is being jeopardized by a heightened regulatory scrutiny.

In 2010, the F.D.A.  granted 19 premarket approvals, down from 48 in 2000.