Collaborating with the USA FDA on Unique Device Identification

On 17 December 2013, GS1 was accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

The basic underlying issue is the lack of a consistent, standardized way to identify devices. When it comes to doing things like adverse event reporting or aggregating adverse events or other post market surveillance, we don't currently have a way to unambiguously identify devices, which creates all sorts of problems for everyone. UDI provides a standardized, unambiguous identification which supports all these sorts of activities for devices as well.

Jay Crowley

Vice President of UDI Services and Solutions, USDM Life Sciences

Results

On 17 December 2013, GS1 was accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).

Global GS1 standards meet the U.S. government’s criteria for issuing UDIs and is helping manufacturers comply with the requirements of the FDA UDI regulation, to support patient safety and supply chain security.

Situation

Following the case of the breast implants manufactured by the PIP Company in Europe and other recent scandals, the United States Food and Drug Administration (FDA) and other regulators in the IMDRF (International Medical Device Regulator Forum), have made patient safety a strategic priority by developing legislation for Unique Device Identification (UDI).

UDI is expected to improve patient safety and Healthcare business processes. A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI by all Healthcare stakeholders worldwide.

More information https://www.gs1.org/healthcare/udi

Approach

The U.S. FDA released, in September 2013 a rule which establishes that a common, worldwide system for product identification should be applied to all medical devices placed on the U.S. market. The rule establishes that:

a unique device identifier number should be assigned by the device manufacturer to each version or model of a device

the unique device identifier should be both in human readable format and in AutoID format. By default, this information will be applied on the label of each device uniquely identified.

UDI should be applied to all medical devices made available on the US market.