According to new research from Emergo Group, a medical device consulting firm based in Austin, Texas, review times for medical device 510(k) premarket notifications by the U.S. Food and Drug Administration (FDA) improved somewhat in 2011 after several years of lengthening review times. The information was culled from publically available FDA data.
Most Class II devices and some Class I and III medical devices submitted for registration in the United States are reviewed via the FDA’s 510(k) premarket notification program before commercialization can begin. The 510(k) process is a less rigorous review of devices before they go on market. When a device passes muster under the 510(k) process, they are “cleared,” whereas a device required to go through the premarket approval application process is “approved.” Emergo’s analysis covered 18,615 records pulled from the FDA website in January 2013.
Emergo found that the number of 510(k) 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. The analysis only looked at 510(k) submissions received by the FDA through Dec. 31, 2011, to allow at least one full year for those submissions to clear. Analysis showed that 95-97 percent of all cleared 510(k) submissions occur within one year of submission.
“FDA 510(k) review times had been steadily climbing since 2006, so it is encouraging to see that trend starting to reverse in 2011,” said Chris Schorre, vice president of global marketing at Emergo Group. “Let’s hope the trend continues.”
Other findings from the analysis were that half of all medical devices submitted for FDA 510(k) clearance fall under orthopedic, cardiovascular, general and plastic surgery, or radiology categories; and that radiological devices typically take the least amount of time to obtain 510(k) clearance (between 60 and 80 days), while clinical chemistry products such as blood glucose testing systems take the longest (180 days).
Although overall review time frames for 510(k) submissions remain higher than 2006-2009, these latest figures suggest that recent efforts to add resources and boost transparency at the FDA may be driving a more efficient medical device regulatory process in the United States. Last year saw the reauthorization of the Medical Device User Fee Act (MDUFA), which upped fees paid to the agency by companies seeking clearance/approval in exchange for faster review times. For its increased fees, industry was promised by FDA in MDUFA a more transparent review process as well as one that is more time-sensitive. That review times were already improving in 2011 before MDUFA was reauthorized bodes well for companies seeking to get their devices on the market faster and more efficiently.