FDA Proposes Unique Device Identification System for Medical Devices

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As required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the U.S. Food and Drug Administration (FDA) issued a proposed rule on July 3, 2012 to establish a unique device identification (“UDI”) system for medical devices marketed in the U.S. The UDI system would require a unique code to appear on the label and package of a device in order to adequately identify the device through its distribution and use. The UDI system is expected to help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDAs proposed rule can be read here.

Under the proposed rule, the UDI is composed of (1) a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and (2) a production identifier, which includes current production information for a device. The proposed rule also requires device manufacturers to submit device information into the publicly available Global Unique Device Identification Database (“GUDID”). GUDID will include a standard set of basic identifying elements for each UDI. The UDI does not indicate, and GUDID will not contain, any information about who uses a device, including personal privacy information.

The proposed rule implements the UDI system through a multi-year risk-based, phased-in approach, focusing on highest-risk medical devices first and exempting low-risk devices from some or all requirements. Exempt devices include:

• Over-the-counter devices sold at retail which have UPC codes;
• Devices delivered directly to hospitals and other health care facilities;
• Class I devices exempted by regulation from the Quality Systems Requirements in 21 C.F.R. 820;
• Products used solely for research, teaching, or chemical analysis and not intended for any clinical use;
• Custom devices;
• Investigational devices;
• Veterinary medical devices;
• Devices intended for export;
• Devices held by the Strategic National Stockpile; and
• Devices for which FDA has established a performance standard.

Once fully implemented, the FDA states that the UDI system will provide multiple benefits, including:

• Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
• Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
• Provide a consistent way to enter information about devices in electronic health records and clinical information systems.
• Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
• Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.

The proposed rule could significantly impact medical device labelers, including manufacturers, reprocessors, and repackagers. Specifically, these labelers will bear the brunt of the cost of implementing the new UDI system. The FDA estimates that the majority of the cost of the proposed rule would be incurred by domestic labelers. Domestic labelers are estimated to spend $588.6 million over the next 10 years to implement the UDI system. The largest component of the estimated cost includes the costs to integrate the UDI system into existing information systems. Other significant components of the cost include costs to redesign device labels to incorporate the required UDI information.

The FDA is currently seeking public comment on the proposed rule for the UDI system (Docket No. FDA-2011-N-0090). Fuerst Ittleman will continue to monitor the developments and changes to the FDAs medical device regulation. For more information, please contact us at contact@fidjlaw.com.