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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We’ve blogged about this quite a lot during the past four years, and it looks to be another case of the more things change, the more they stay the same. Back in June 2011, we reported on an Emergo study, which found that in 2006 it took about 96 days to get clearance. By 2010 that number had leapt to 132. Today, Emergo reports that “it now averages about six months.” Blame for this trend is slung around between industry and regulators. Each time the FDA says it’s made a big step forward, industry tends to toss these stats back in the agency’s face.
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