IOM Report Likely to Address 510(k) Approval Process

The Institute of Medicine (IOM) on Friday will release a report advising the U.S. Food and Drug Administration (FDA) as to how it can refine its medical device approval process to quickly move products to market while preserving patient safety. The FDA requested that the IOM prepare the report as part of Commissioner Margaret Hamburg's commitment to improve the agency’s device unit, which has been beset by high staff turnover and funding difficulties. Among other areas, it is expected to address some of the most hotly debated changes proposed by the agency to its 510(k) program, an accelerated device approval process. Critics believe the accelerated 510(k) process is too widely used and contend that it leads to inadequate testing of some risky devices. However, its industry supporters deem necessary to allow technologies to reach patients at a more rapid clip. Changes to the program, proposed almost one year ago, include the creation of a new category of more risky devices that would require more data prior to receiving FDA approval.