Manufacturers Struggle To Determine Unique Device Identification's Impact

摘要

More than two months after FDA released a 164-page proposed rule aimed at creating a Unique Device Identification system, manufacturers are scrambling to figure out how UDI will affect quality system processes and procedures. The proposed regulation, released July 3, outlines a UDI system that would more quickly identify adverse events, make product recalls more efficient and boost patient safety, among other purported benefits.