US FDA urged to close loophole allowing 510(k) clearance of Class III devices
This article was originally published in SRA
Executive Summary
All high-risk medical devices that were allowed on to the US market by the Food and Drug Administration under the less-stringent premarket notification or 510(k) review process should undergo full-blown premarket approval and the FDA should take immediate steps to frame supporting regulations, the Government Accountability Office says in a report1.