On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer, the specific model of a device, and other information such as batch or lot codes, serial numbers, and expiration dates. The UDIs are intended to improve accuracy of adverse event reports, reduce medical errors by more precisely identifying devices, and make product recalls more effective. The FDA will also use the UDIs to create a centralized database in which consumers can look up information about specific devices.
For medical device manufacturers, this means new labeling requirements. Manufacturers have differing deadlines to comply depending on the type of device they market. Manufacturers of class III (high risk) devices must apply UDIs to their product labels within 1 year of the new rule (by September 24, 2014). Class II medical devices must comply within 3 years (by September 24, 2016), and Class I devices must comply within 5 years (by September 24, 2018).
However, many products are exempt from the UDI requirement, including:
- Devices already manufactured and labeled on the compliance date for that class of device;
- Individual, single-use, non-implantable devices not intended for individual sale;
- Devices solely for research or teaching;
- Investigational devices;
- Veterinary devices; and
- Devices intended for export from the U.S.
In addition to marking the labels of products, devices that are intended for multiple use and are reprocessed between uses must bear the UDI as a permanent marking on the device itself, although different deadlines apply than those for marking labels. See the chart here for reference. Manufacturers should read the new rule, determine their deadline for compliance, and formulate a plan to ensure their products comply.