Interview: FDA’s UDI Architect Jay Crowley on the Agency’s Approach to UDI and Pending Changes
The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device Identification (UDI) rule, the US regulator wants to build a system that allows for safer, more accountable medical devices. But that process, which is global in scale, is not without significant challenges. In the wake of a flurry of UDI activity in recent weeks, we called up FDA’s Jay Crowley, senior adviser for patient safety at the Center for Devices and Radiological Health (CDRH) and the regulator responsible for FDA’s UDI effort, to talk about the philosophy and status of the UDI program, as well as what comes next for regulators and industry.