Feature | September 25, 2013

FDA Finalizes New System to Identify Medical Devices

Rule will help to improve patient safety

September 25, 2013 – The U.S. Food and Drug Administration (FDA) announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The 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 in the development of this rule.  

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., JD, director of the FDA’s Center for Devices and Radiological Health.

The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date when that information appears on the label.

The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.

The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.   

“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients, as well as faster, more innovative and less costly device development,” said Shuren.

The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.

The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.

In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.

For more information: www.fda.gov

Related Content

CHLA/USC Team Designs Novel Micropacemaker

Model of the human heart with microprocessor located in the pericardial sac and attached to the left ventricle. Graphic courtesy of Business Wire.

News | Pacemakers | June 29, 2018
Investigators at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) have...
Permanent Pacing Effective for Older Patients With Syncope and Bifascicular Block
News | Pacemakers | May 24, 2018
Syncope with bifascicular block may be caused by intermittent complete heart block, but competing diagnoses may coexist...
Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System Detects Atrial Contractions, Restores AV Synchrony
News | Pacemakers | May 24, 2018
New clinical study results demonstrate that an investigational algorithm, utilizing the accelerometer signal in the...
The Boston Scientific Essentio MRI-safe pacemaker.

The Boston Scientific Essentio MRI-safe pacemaker. It is common for pacemaker patients to need magnetic resonance imaging (MRI), which has not previously been possible because the magnetic fields could damage older devices. All pacemaker vendors now have FDA-cleared MRI compatible pacemakers. 

Feature | Pacemakers | February 13, 2018 | Dave Fornell
There have been several advancements in pacemaker technologies over the past few years.
Mexican Doctors Safely Reuse Donated Pacemakers After Sterilization

Mexican government reports conclude more than half of the population does not have access to social security or private insurance that covers a pacemaker implant, and 44 percent live in poverty. Recycling donated, explanted pacemakers offers a new option for these patients.

News | Pacemakers | November 10, 2017
Mexican doctors have safely reused donated pacemakers after sterilization, shows a study presented at the 30th Mexican...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers | June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Videos | Pacemakers | May 23, 2017
Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospita
micra leadless pacemaker
Feature | Pacemakers | May 16, 2017
May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Regist
Videos | Pacemakers | May 16, 2017
This video, provided by Medtronic, demonstrates the implantation of Micra transcatheter pacing system (TPS).
closed loop stimulation, DDD-CLS, ACC17, SPAIN trial
Feature | Pacemakers | March 22, 2017
March 22, 2017 — Patients with recurrent fainting episodes (syncope) who received a pacemaker delivering a pacing pro
Overlay Init