In March, the Advancing Patient Safety Coalition, representing 24 healthcare companies, reiterated to FDA its interest in the implementation of a mandatory medical device unique device identification (UDI) system. A UDI system was mandated in the FDA Amendments Act of 2007, but the center has appeared too overwhelmed to do much about it. In a letter to Commissioner Andrew von Eschenbach, the coalition said an identifier “is a crucial factor in improving patient safety, reducing medical errors, facilitating device recalls, improving device adverse-event reporting, and improving postmarket surveillance efforts.” The letter called on FDA to move as quickly as possible to promulgate regulations implementing the new law’s UDI provision. Six months later, in a presentation to the Regulatory Affairs Professionals Society’s annual meeting in Boston, CDRH director Daniel Schultz said developing a UDI system continued to be a priority for the center. He said that CDRH was now “well into” developing a regulation. “This has to happen sooner rather than later,” Schultz said. “We are working on an advanced notice of proposed rule making coming out in the not-so-distant future. We are coming out with a very comprehensive document that will ask a lot of questions on how this should be done. “We ask that all of you examine it and give us your feedback,” Schultz said. “Clearly, we understand that this is a very diverse industry and different from drugs and biologics, and we need to come up with a strategy that meets the needs of the industry in total.” —James G. Dickinson