Comment period for FDA's UDI system proposed rule to close

Numerous organizations have commented on the FDA's July proposed rule for a unique device identifier (UDI) system. The system would track medical tools, allowing for prompt recall of any devices deemed dangerous to patient safety.

The proposed rule would require manufacturers to place UDI codes on each device identifying: make; manufacturer; and lot number.

A public database would store the codes so regulators, physicians and companies could monitor safety issues related to the devices. The FDA included a seven-year implementation plan for the UDI system in its propsed rule.

Last week, the Premier healthcare alliance submitted a comment letter urging the FDA to accelerate its timeline for implementing unique device identifiers for medical devices. Premier called for the FDA to shorten its implementation schedule by requiring all classes of medical devices to have a UDI code on their label or packaging within two years and directly on the equipment within three years.

Premier also recommended that the FDA:

• Exempt healthcare providers from UDI labeling requirements when they are repackaging devices for internal use;
• Establish the UPC code as the UDI for certain products sold in retail stores, such as insulin syringes and glucometers; and
• Change the proposed date format for medical device labels to the international distribution standard.

More than 60 individuals and organizations have submitted comments on the proposed rule including:

• BayCare Health System in Florida, which expressed concern that the UDI system would impose new data collection and reporting burdens on hospitals; and
• South Georgia Medical Center, which expressed concern that the UDI system would require healthcare providers to use a device tracking tool that charges a fee.

The public comment period for the proposed rule ends Nov. 7.