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www.fdanews.com/articles/134550-new-8216-innovation-8217-path-could-change-device-trials

New ‘Innovation’ Path Could Change Device Trials

February 24, 2011
The CDRH has proposed a new pathway to expedite approval of the most innovative devices that could change the way clinical trials are conducted for those devices. The new initiative, dubbed the “innovation pathway,” is the core component of a multi-pronged program to minimize delays that can occur when pioneering devices raise novel and challenging scientific questions. The center proposes a review time frame of 150 days, approximately half the time it takes to review most PMAs.
Clinical Trials Advisor