Ask any medical device manufacturer about U.S. Food and Drug Administration 510(k) pre-market notifications and they will probably express frustration over the rather long review process. But a new analysis from the Emergo Group, an FDA regulatory consultant for medical device companies, shows a trend in a different direction.

Emergo Group found that review times for most Class II (and some Class I and III) medical devices by the FDA improved slightly in 2011 after several years of lengthening review times. Submissions cleared by the FDA within three months improved to 42 percent in 2011 from 40 percent in 2010; average 510(k) review times also fell to 138 days in 2011 from 146 days in 2010, according to the analysis.

In addition, out of the various types of devices that applied for 510(k) — radiology, orthopedic, cardiovascular, general and plastic surgery — radiological devices typically took the least amount of time to receive market clearance from the FDA. Radiological devices took between 60 and 80 days for approval of premarket applications. U.S. law requires a deadline of 180 days.
While it's difficult to attribute a single factor to the shortening review times, Elisa Maldonado-Holmertz, vice president of business development at Emergo Group, told DOTmed News that it might be attributed to the FDA doing a better job of educating device companies on 510(k) submissions, or that the FDA is rejecting more 510(K) submissions from the outset.

Another factor involved staffing and experience within the Center for Devices and Radiological Health (CDRH), according to Maldonado-Holmertz.

"One thing is certain, the FDA has been under pressure by industry and Congress to shorten review times," she said.

Emergo Group's analysis covered 18,615 public records pulled from the FDA's website in January 2013. However, they only reviewed submissions received through December 31, 2011 to allow at least one full year for those submissions to clear. According to Emergo, 95 to 97 percent of all FDA clearances occur within one year of submission.

Although industry stakeholders hope the trend will continue, the real possibility of federal budget cuts , under so-called sequestration or otherwise, would certainly have an effect on review times.

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