Back in 2007, Congress passed legislation requiring the FDA to develop regulations to establish a unique device identification system for medical devices. The UDI system can help the FDA find problems with medical devices much earlier, track recalls more efficiently, and improve patient safety. Since that time, the FDA has been working with medical device manufacturers, industry experts, and patient and consumer groups, conducting pilot studies and gathering information to create the proposed rule. To minimize industry costs and speed implementation, the proposed rule builds upon current standards and systems already in use by some companies.
The UDI would include a unique device identifier code specific to a device model, and a product identifier that includes current production information for that device. UDI information will be stored in a publicly available UDI database. Over-the-counter devices sold at retail stores would be exempt from the FDA rule, since these types of items have a UPC code in place.
The UDI system provides important benefits including reducing medical errors, rapid identification and tracking of defective medical devices, and more useful electronic patient records.
The FDA is seeking comment on the proposal for 120 days. A final rule would become effective in stages, over a period of seven years. For more information, and details on how to comment on the proposed ruling, read Proposed Rule: Unique Device Identification System.