Innovation, Faster Reviews Top U.S. FDA Device Goals in 2012

The U.S. Food and Drug Administration plans to begin triaging premarket submissions April 1 to improve efficiency and strengthen premarket reviews. The pilot program is one of several initiatives focused on innovation and the device approval process outlined in the Center for Devices and Radiological Health’s (CDRH) 2012 strategic report. The center also plans to publish a proposed rule on acceptance of foreign clinical studies, evaluate its policies and infrastructure around medical software and wrap up its review of Class III preamendment devices.
International Medical Device Regulatory Monitor