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FDA: Factoring In Reimbursement, U.S. Bests Europe In Access To Innovative Devices

FDA officials refute claims, frequently made by industry, that because FDA’s PMA review process is much slower than the CE mark regulatory process in Europe, Americans suffer delayed access to innovative and life-saving technology.

Patients gain access to innovative, high-risk devices in the U.S. at about the same rate as in the United Kingdom and Italy and faster than in France and Germany if both regulatory approval time and reimbursement availability are factored in, two FDA officials argue in the New England Journal of Medicine.

In an article published online Aug. 1, the officials attempt to counter claims, frequently made by industry, that because FDA’s...

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