The FDA issues a UDI rule … at last

It was years in the making. But in September, the U.S. Food and Drug Administration issued a final rule on unique device identification or UDI, as well as a global database for all medical devices. As expected, the highest-risk (class III) medical devices will be first out of the chute. Many low-risk devices will be exempt from some or all of the requirements in the final rule. The final rule follows by 14 months the FDA’s proposed UDI rule. (See October 2013, Journal of Healthcare Contracting.) The UDI system consists of two core items, according to the agency:

  • 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.
  • A publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID), which will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center, according to FDA.

Once fully implemented, the UDI system rule is expected to 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, says FDA. It will also offer a clear way of documenting device use in electronic health records and clinical information systems. To view the FDA’s final rule on unique device identification, go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm


Side bar: What is a UDI? A UDI is a unique numeric or alphanumeric code consisting of two parts: 1. A device identifier (DI), which is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. 2. A production identifier (PI), which is a conditional, variable portion of a UDI that identifies one or more of the following:

  • The lot or batch number within which a device was manufactured.
  • The serial number of a specific device.
  • The expiration date of a specific device.
  • The date a specific device was manufactured.
  • The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

Source: U.S. Food and Drug Administration


Side Bar: Timetable for UDI implementation

Compliance date Requirement
One year after publication of final rule (Sept. 24, 2014) • The labels and packages of class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. (A one-year extension may be requested no later than June 23, 2014.) • Class III stand-alone software must provide its UDI.
Two years after publication of final rule (Sept. 24, 2015) • The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.• A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.• Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database.
Three years after publication of final rule (Sept. 24, 2016) • Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. • The labels and packages of class II medical devices must bear a UDI. • Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.
Five years after publication of final rule (Sept. 24, 2018) • A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.• The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI.• Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.• Class I stand-alone software must provide its UDI.
Seven years after publication of final rule (Sept. 24, 2020) •Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

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