The U.S. Food and Drug Administration (FDA) is asking for public comments on last week's report from the U.S. Institute of Medicine (IOM) on the agency's 510(k) process for regulating medical devices.
Released on July 29, the IOM study blasted the 510(k) process, stating that it fell short in assessing the safety and effectiveness of medical devices. In particular, the report said that the process by which new 510(k) applications are compared to previously cleared devices was flawed and should be scrapped.
The IOM report was produced at the request of the FDA as part of a regulatory review process that began in 2009. As the next step in the process, the FDA said it plans to take public comment on the report through September 30, 2011. Those interested in commenting can get more information by clicking here.
