There has been a consistent criticism that it takes longer to have a high-risk medical device in the United States than in Europe.  This argument has been used to bolster an argument that the FDA should lower its standards for approving medical devices, which is denying Americans access to innovative technology. According to an article in the New England Journal of Medicine this might not be the case.  It points out that a review of data suggests it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the U.S. as it does in the four largest European markets (Germany, France, Italy and Britain).