Getting medical devices to market faster - US FDA focus for 2014/2015
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration's Center for Devices and Radiological Health has published a two-year strategy describing how it plans to establish a faster pre-market approval pathway for high-risk devices for unmet medical needs and speed up the safe initiation of clinical trials. CDRH director Jeffrey Shuren talks to Rebecca Kern.