FDA Postmarket Team Takes Action

These actions include creating internal performance measures that track how CDRH is handling postmarket issues (such as recalls), revising the system that records reported adverse device events, and increasing the use of the Medical Product Safety Device Network. CDRH Director Dan Schultz called the plan a major step in the direction of providing a postmarket system that, through learning and feedback, ensures the safe and effective use of devices while continuing to encourage innovation.