Premarket Approval pathway

The U.S. Food and Drug Administration's Premarket Approval pathway allows high-risk medical devices on the market with only one study to prove their safety and effectiveness, and there are a limited number of studies done post-market, according to research published in Journal of the American Medical Association. Medical device regulation in the U.S. is more rigorous than in other parts of the world, but "the difference is, in many European countries they have much better capacity to follow devices once they are in practice," senior author Joseph S. Ross, M.D., of the Yale University School of Medicine, told Reuters.

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