In 2007 the FDA performed a thorough review and approved 27 medical devices and non-drug treatments, out of 41 applications for which a decision was reached.  Yet, during the same time period, 3,052 new applications were deemed "substantially equivalent" to existing technology and given only a cursory review – of which 2,640 were approved.  [See New York Times article.]

However, for drug therapies, the FDA's approval process is much slower. Before approving medications, the FDA requires they go through extensive trials involving thousands of people, over many years before patients have access to promising new drug therapies, and the process can cost upwards of a billion dollars.

It appears the model the FDA follows to fast track most medical devices is superior to the way the FDA currently evaluates new drug therapies.