FDA’s unique device identification (UDI) system, established in 2013 as a means to identify and track devices through distribution and use, is taking some time for implementation. The UDI system was expected to be implemented in stages over a seven-year period to allow for manufacturers to comply. In establishing this system, the goal is to have device data available electronically, to reduce medical errors, and to have more accurate reporting of adverse events for a more rapid solution to reported problems and FDA communications to the public.
This transition to UDI on the labeling is a costly and difficult change for the industry in its device labeling documentation. The rule requires a UDI be provided on the device label using automatic identification and data capture (AIDC) technology so that it can be automatically entered into an electronic patient record or other computer system for tracking. FDA is extending deadlines, according to Michael Mezher, RAPS. Read his entire article here for details on dates and specific devices included in the FDA extensions. The patient comes first and the extensions seem to be necessary to avoid any problems with patient access to devices.