FDA published the final rule on the Unique Device Identification System on September 24, outlining requirements for manufacturers to label medical devices. The finalization of the long-awaited rule starts the countdown toward compliance dates, with manufacturers of high-risk medical devices required to comply first.
Class III devices are required to carry unique device identifiers within one year. However, FDA will allow manufacturers to petition to extend the implementation period if public health and supply disruption issues arise.
Most Class II devices will need to meet the new requirements in three years.
Class I devices that are nonexempt from the UDI requirements will have five years to comply.
Other notable changes FDA made between the proposed and final rules include:
- Removal of direct part marking (DPM) requirement for implantable devices, though DPM is still required for products that are used more than once or reprocessed.
- The date provided on device labels will follow a more internationally accepted format: YYYY-MM-DD. The compliance dates mirror the UDI labeling requirement timeline.
- Inventory currently packaged and labeled will be exempt from UDI regulations for three years.
- Combination products and kits do not require individual UDI labels for each part, but one label per kit.
The UDI system has two main elements: 1) assign each version or model of a device a unique number that includes production information such as lot or batch number, expiration date and manufacturing date when that information appears on the label; 2) develop the publicly-searchable Global Unique Device Identification Database (GUDID) to house a catalogue of every device with an identifier. Once implemented, the system is expected to identify product problems quicker, better target recalls and improve patient safety.
The following articles provide detailed advice on how to implement and comply with UDI:
For more on the final rule:
OMTEC 2014 will offer a special focus on UDI compliance. Submit an abstract to share your expertise on the topic with device manufacturers and suppliers.