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Michael Causey

FDA Compliance

Independent Study Finds FDA 510(k) Review Process Has Slowed

Be prepared to defend what you submit, warns analyst

Published: Tuesday, July 5, 2011 - 14:52

Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification  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 although 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 raw data from a new study 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 Emergo’s Stewart Eisenhart did note that the numbers show clearly that 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 percent 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 percent of 510(k) submissions from January 1, 2006, to May 23, 2010, were cleared within three months, and more than 80 percent 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.


However, Hogan Lovell’s partner John Smith, an expert on navigating the FDA for medical device firms, says the “new FDA” is a lot tougher for medical device manufacturers 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. Smith recently worked with a medical device manufacturer from which the FDA had never before demanded patient study data. But this time, it did insist the company conduct a 60-patient study. “It slowed the process,” Smith says.

“I think the FDA reviewers ask a lot more questions than they did, say, 10 years ago,” says Eisenhart. “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 midsize 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 during the past year.

Emergo works with medical device firms of all sizes, but the bulk of its 510(k) consulting work is with small to midsize shops. “We have no agenda,” Eisenhart maintains.

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 back up 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,” he says.


This article first appeared in the June 27, 2011, edition of the AssurXblog.




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.