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The regulatory system in place in the U.S. is often touted as the foundation of patient and device safety. However, 76% of companies recently surveyed indicated that requirements for U.S. Food and Drug Administration's 510(k) product review process were unclear. The regulatory burden seems greater for small medical device and diagnostic companies: two-thirds are obtaining clearance for new products in Europe first. Product review time is twice as long in the U.S. as in Europe. What can be done to streamline the product approval process?
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