Independent Study Finds FDA 510(k) Review Process Has Gotten a Lot Slower

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Well, this is getting interesting. For the past several months we’ve had relatively partisan folks on each side (device industry vs. FDA) either saying the FDA Review Process  510(k) process wasn’t doing so badly (the FDA) or that it was too slow and restrictive of innovation (the medical device industry) or suggesting that the review process was slowing because the other guy was screwing up.

And while a number of industry-sponsored studies have been critical of the FDA for a slower review process, FDA supporters (well, mostly, the FDA) have shot back that studies funded by industry tend to “discover” what industry wants discovered.

Now we’ve got a very raw data type of new study survey from the Emergo Group that is not funded by either side and was conducted by a group that maintains it has no dog in this fight. Noting that the FDA’s overall track record isn’t that bad in many ways, the Group’s Stewart Eisenhart did note that the numbers show clearly it now takes a lot longer to get a 510(k) review than it used to…and he’s not surprised.

Emergo’s analysis finds that application times jumped 37% from 2006 to 2010. In 2006 510(k) applications cleared by the FDA took about 96 days, but that number soared to 132 days in 2010.

More than 53% of 510(k) submissions from January 1, 2006, to May 23, 2010, were cleared within three months, and more than 80% made it through within six months, according to the report. Eisenhart said the FDA should feel proud of its record in that arena, at least.

More than 80% of all companies submitting a 510(k) are able to obtain FDA Premarket Notification clearance for their medical device within 6 months.

Hogan Lovells Partner John Smith an expert on navigating the FDA for medical device firms, says the “new FDA” is a lot tougher for medical devices companies to work with when it comes to 510(k)’s.

Example: the FDA has raised the bar on data requirements for devices it wouldn’t have held to that standard in the past. He recently worked with a medical device that the FDA had never before demanded patient study data. But this time, it did insist the medical device company conduct a 60-patient study. “It slowed the process,” he told us last week (June 23).

“I think the FDA reviewers ask a lot more questions than they did, say, ten years ago,” Emergo’s Eisenhart told us June 23. “It’s difficult to say this is all the FDA’s fault, but the medical device industry is definitely under more scrutiny from reviewers now” during the 510(k) process.

Dealing with the FDA is “a very sobering experience” for small and mid-size companies that may think they know what the FDA wants, but learn that some of the rules have changed, Smith said. His firm has worked on about 300 510(k)’s in the past year.

Emergo works with medical device firms of all sizes, but the bulk of their 510(k) consulting work is with small to mid-size shops. “We have no agenda,” Eisenhart stressed.

So given today’s tough regulatory climate, does Eisenhart have any advice for a medical device firm about to embark on a 510(k) with the FDA? “Be prepared to backup all that you submit, be prepared for more questions, and know that if you are a repeat applicant, it is not the same process anymore.”


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