FDA Publishes Proposed Rule for UDI System

Progress is being made in the U.S. Food and Drug Administration’s (FDA) UDI program. Ever since Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices, the FDA has been working closely with industry, the clinical community and patient and consumer groups, and has conducted four pilot studies.

Now the FDA has published proposed rules for the UDI system. Part of that proposal includes what the UDI labels will look like. UDI labels will include a picture, a barcode for tracking, and a description of the product. UDIs will also include a serial and batch number to assist tracing the product back to its place of origin and manufacturer. This information will make it easier to determine which company is responsible to the defective products. The figure depicts what a UDI label looks like for a fictitious medical device.

The FDA’s current proposal requires UDI labeling on all product packaging and directly on implantable devices to make sure they can be identified. UDIs will also be applied on reusable products that are repeatedly sanitized and embedded in the microchips of electronic devices.

Once the FDA’s proposal is approved, the new labels will be phased in over several years. Class III medical devices, such as pacemakers, will require UDI labeling one year after the law goes into effect. The FDA will require class II devices, such as artificial knees, to add UDIs three years after the law is finalized.

You can find the complete published proposal here.