You Should Know Newsletter
The size of the United States medical device market is expected to surpass $133 billion by 2016. At $110 billion, it is currently the largest medical device market in the world.
A 2011 study found that 71 percent of Class I medical device recalls (those deemed most likely to cause serious adverse outcomes or death) were cleared through the FDA’s 510(k) fast-track approval process. 1,190 Recalls According to a recent FDA report, recalls of defective medical devices nearly doubled from 2003 through 2012: 1,190 in 2012 compared with 604 in 2003.