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FDA Compliance

FDA Proposes Unique Device Identification System for Medical Devices

UDI system could improve quality of information in medical device adverse-events reports

Published: Monday, July 9, 2012 - 13:22

(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

A UDI system has the potential to improve the quality of information in medical device adverse-events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community, and patient and consumer groups, and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

“The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” says FDA Commissioner Margaret A. Hamburg, M.D. “The unique identification system will enhance the flow of information about medical devices, especially adverse events, and as a result will advance our ability to improve patient safety.”

With certain exceptions, under the proposed rule, a UDI would include:
• A device identifier, which is a unique numeric or alphanumeric code specific to a device model
• A production identifier, which includes the current production information for a device

The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.

The proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients and consumers, and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds on current standards and systems already in use by some companies.

A UDI system can 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 its characteristics
• 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 health care 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

For more information, see the FDA’s Proposed Rule: Unique Device Identification System.


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FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.


The entire concept of

The entire concept of improved tracking throughout a supply chain and eventual patient use is a very honorable and necessary process today. I am glad that the FDA released the ruling for individual marking of most medical devices. The concept of UDI has been around for decades and has proven it's worth with the U.S. Department of Defense and more. http://www.id-integration.com/medical-devices.html