RPT-Preview Report Could Sway U.S. FDA Device Review Process

The Institute of Medicine is poised to advise the U.S. drug regulator how it can refine its medical device approval process to get products to market quickly while protecting patients. The Food and Drug Administration requested the IOM report as part of Commissioner Margaret Hamburg's vow to improve the FDA's device unit, an area dogged by high staff turnover and funding woes. Friday's report by the influential nonprofit organization is expected to address some of the more contentious changes proposed by FDA to the accelerated device approval process, known as the 510(k) program.