Is FDA Really Streamlining Its PMA and 510(k) Processes?

In the early aughts, if a medical device manufacturer wanted to get its product to market—any market—more quickly, it often obtained a CE Mark first. At the time, the European Commission required less clinical trial data than FDA. Even for some Class III devices, clinical data would need to justify safety claims but not efficacy. Efficacy was for the market to decide.