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Michael Causey

FDA Compliance

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

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

Published: Wednesday, July 15, 2015 - 12:27

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.

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.

The FDA can’t exactly point to any kind of consistent improvement. It approved 3,173 devices working their way through the 510(k) maze in 2014, which was up nearly 5 percent from 2013, but pretty much in line with 2011 and 2012. Check back in a year or two to see if 2014 was the start of a positive trend.

Radiological and orthopedic devices are usually the fleetest of foot in the race for approval, averaging about 140 days last year. That’s up from 135 in 2013. Overall, about 22 percent of devices are cleared within three months.

The study also finds that third-party reviewers tend to work more quickly than internal agency reviewers. Although not all devices qualify for this program, think about grabbing it if you can. Your device might clear in 68 days, on average, or more than 110 days faster than with an internal FDA reviewer.

Note: The FDA doesn’t release data about submissions rejected, withdrawn, or abandoned by the submitter. Emergo’s analysis doesn’t include devices subject to the Premarket Approval process.

So, still trying to figure out how your new medical device might fare in today’s FDA climate?

A fun new tool from Emergo just might sweep aside some of the fog. Simply plug in (or look up) your device product code, then sit back and let the tool tell you an estimate approval time based on similar products that have gone through—and survived—the process.

Unfortunately, you probably don’t need any kind of online tool to tell you one thing: The FDA’s 510(k) approval process keeps getting slower and slower and slower.

First published June 23, 2015, on the AssurX blog.

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About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.