Scientific Publications by FDA Staff

N Engl J Med 2012 Aug 9;367(6):485-8

Patient access to medical devices--a comparison of U.S. and European review processes.

Basu S, Hassenplug JC

The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.(1) This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans' access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four . . .