The FDA Unique Device Identification (UDI) Rule will establish a single device identification system that is consistent, unambiguous, standardized, and global. All manufacturers of medical devices will be required to comply with the new UDI rule. It was announced at the conference that the UDI rule is expected to be available for comment late in the first quarter or 2011, with the final rule issued by the end of 2011.
Once the UDI rule becomes mandatory, medical device manufacturers will need to mark their products with a Unique Device Identifier. Implementation of the rule will be phased-in, based on the medical device’s classification. Medical devices are classified into three groups: Class I, II, and III. Basically, each class represents the level of regulatory control necessary to assure the safety and effectiveness of the device, with control increasing from Class I to Class III.
Class III devices must have UDI marks within 12 months of the rule going into effect. The devices in Class III are those which have the most risk of injury or illness. An example of a Class III device is an implantable pacemaker. Class I devices will have up to 60 months to comply. Class I devices are those that are most in use and have less risk of illness or injury, for example, elastic bandages or some hand-held instruments.
Medical device manufacturers have been aware of the the UDI rule since 2007 (Food and Drug Administration Amendments Act of 2007, Sec. 226), and some of the larger medical manufacturers, such as Becton Dickinson, already have their UDI programs in place. However, smaller manufacturers and the makers of Class I devices have decided to wait until the UDI rule goes into effect before complying.
Why so? It seems that early implementation of the UDI would benefit public health and patient safety, but some manufacturers hope to avoid the false starts and high implementation costs associated with putting a system in place before the UDI rule becomes final. In response, the Global Harmonization Task Force has published its “Unique Device Identification (UDI) System for Medical Devices”, which they hope will be a good template on which to base a UDI system that will comply with the FDA’s final ruling. This guide is intended to ease implementation of UDI and offers recommendations for an effective UDI system. For example, the guide suggests that the GS1 system and the health industry bar code (HIBC), which are internationally accepted coding systems, be adopted and implemented.
If you would like to read more about the potential and actual issues that would arise for labelers implementing UDI, read the FDA’s publication “Results of FDA Pilot Activities To Explore Opportunities and Challenges With the Implementation of a Unique Device Identifier System“.
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