SAN JOSE, Calif. – The time it takes medical devices to get approval for for use in the U.S. is showing the first small signs of improvement since 2006, according to a study by a consulting firm.
In 2011, the U.S. Food and Drug Administration (FDA) approved 42 percent of medical devices it submitted under its 510(k) process within three months, up from 40 percent in 2010, said the Emergo Group. Average 510(k) review times also fell to 138 days in 2011 from 146 days in 2010.
“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 for the regulatory consulting company, in a press statement.
Despite the improvements, Emergo said overall 510(k) review times remain higher than 2006-2009. However, the figures suggest recent efforts to add resources at the FDA may be a sign of advances, it said.
Among other results, Emergo found radiological devices typically take the least amount of time to obtain 510(k) clearance (between 60 and 80 days). Clinical chemistry products such as blood glucose testing systems take the longest (180 days).
Emergo’s analysis covered 18,615 records pulled from the FDA website in January 2013. The vast bulk of medical devices use the 510(k) process, which is geared for products that are enhancements of previously approved devices.
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