Jay Crowley, FDA
It was a long time coming, but FDA at long last issued its final rule on unique device identification (UDI) systems for medical devices this year. While FDA and industry have historically not seen eye to eye on many issues, the final UDI rule appeared to adequately satisfy all parties—a rarity these days. And bringing these famous frenemies together was Jay Crowley, senior advisor for patient safety at CDRH. Crowley facilitated the accord, with FDA ultimately making some crucial concessions to industry. "Jay Crowley should really be commended for all his hard work and diligence on this," notes Frank Pokrop, director of regulatory affairs at Carefusion and chairman of MD+DI’s editorial advisory board. "FDA's been very good about offering consultations and exemptions. It’s a major change for the industry, but everybody should be happy with it."