The FDA said it will set up a team of outside medical experts to study the safety of heart devices currently on the market. The decision is a step in a new direction for the agency, which has historically relied on internal advisory panels to review the safety of drugs and medical devices. The announcement comes days before the release of a report by the Heart Rhythm Society, an influential cardiologists group, which is expected to recommend major changes in the way safety issues are handled. The FDA's oversight of medical devices has remained a hot issue in Washington since last year when Guidant recalled thousands of potentially dangerous defibrillators and pacemakers after it was learned that they contained a manufacturing defect that caused them to short circuit in some cases.
- see this article from The New York Times