CDRH Responds to Device Safety Concerns, Outlines New Initiatives

Dismissing concerns that CDRH’s device review process may need fixing, agency officials say several new initiatives are under way that will focus on device safety and more thorough premarket and postmarket reviews. Catherine Cook, CDRH’s associate director for regulations and policy, said the agency plans to ramp up its device review process with a focus on postmarket surveillance.
Devices & Diagnostics Letter