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Study: FDA 510(k) Approval Process Now Averages Six Months

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For some device manufacturers, third-party reviewers could reduce that to 68 days

If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device clearances between January 2010 and December 2014.

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