FDA Mandating Unique IDs for Medical Devices

The agency's rule will require most Class III devices, such as automated external defibrillators, to have unique device identifiers on their label and packaging within a year.

A Sept. 20 final rule published by the U.S. Food and Drug Administration will require manufacturers of medical devices to assign unique identifiers to them. The use of the Unique Device Identification system will give the agency and the industry a consistent way to identify medical devices throughout their distribution and eventual use.

"Most devices may be required to have a code on their label and packaging, and for certain devices, on the product itself, in plain text and a machine-readable format, like a bar code. This code will correspond to the specific model or version of a device and will include production information, such as the lot number and expiration date. It will also provide a link to a publicly available database – called the Global Unique Device Identification Database – where you can find information about some of the devices’ key characteristics, such as model and brand – but no identifying patient information will be stored there," Dr. Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health, explained in a Sept. 20 post to an FDA blog. "FDA worked with the health care community and the device industry to develop a system that will provide a clear way of documenting device use in electronic health records and clinical information systems."

FDA published a proposed rule for this purpose in July 2012.

The UDI system consists of two core items: a unique number assigned by the device manufacturer to the version or model of a device, which includes production-specific information such as a lot or batch number, expiration date, and manufacturing date when that information appears on the label; and the database administered by FDA.

The agency is phasing in the UDI system. High-risk medical devices in Class III, which includes automated external defibrillators, heart valves, and artificial hips, will be required to have unique device identifiers on their label and packaging within a year. Manufacturers will have three years to act for most Class II (moderate risk) devices and five years for Class I devices. Some Class I devices will be exempt from UDI requirements completely, however.

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