FDA's first-time PMAs down drastically so far in 2013

The FDA granted only 9 first-time premarket approvals in the first half of 2013 and a single humanitarian device exemption, EP Vantage notes in a new report. That's a 47% drop from 19 PMAs issued in the first half of 2012. It can be hard to quantify the drop because PMA rates can vary from year to year, Janet Trunzo, AdvaMed's executive vice president for technology and regulatory affairs, told FierceMedicalDevices. But she added that "we are hopeful the new medical device user fee agreement that went into effect Oct. 1, 2012--with its robust FDA performance goals and added resources--will help the agency improve the efficiency and predictability of the device review process." Report

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