FDA Won't Immediately Dispatch Investigators, 'Guns Blazing,' To Enforce UDI Regulation

摘要

FDA is still working out an enforcement strategy to ensure compliance to upcoming Unique Device Identification (UDI) requirements, but some details are starting to come into view. "There have been a number of questions asked about our enforcement plan and what we're going to do," Jay Crowley, CDRH's senior advisor for patient safety, said Sept. 19 at a two-day UDI conference convened by FDA in Orlando, Fla. Although he noted that the agency hasn't developed a formal enforcement plan yet, Crowley assured manufacturers that FDA will not "send out a thousand investigators, guns blazing, on the first day of [UDI] implementation."