Most U.S. device firms seek overseas regulatory approval first

10/7/2011 | (Boston)

A Northwestern University report found that more than 75% of U.S. medical device firms turn to overseas markets first before filing for a 510(k) clearance, driven in part by unpredictability, high costs and long review times associated with the FDA process. The study, commissioned by the Institute for Health Technology Studies, was a counter response to an Institute of Medicine report that called for the elimination of the 510(k) process.

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