Regulatory Focus™ > News Articles > GS1 Obtains FDA Accreditation to Administer UDI Standard

GS1 Obtains FDA Accreditation to Administer UDI Standard

Posted 17 December 2013 | By Alexander Gaffney, RAC

Medical device manufacturers looking to comply with the US Food and Drug Administration's (FDA) new Unique Device Identification (UDI) rule will now have a new accrediting agency from which to obtain an identifying mark.

Background

FDA released its final UDI rule in September 2013, reflecting a wide range of changes called for by industry. The rule, at its most basic, requires most medical devices to be given a unique identifying mark.

The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.

The rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.

But those identifiers aren't being assigned by FDA. Instead, they're being assigned by outside accredited issuing agencies that enforce FDA's standards and ensure consistency and uniqueness among assigned numbers.

GS1: Newly Accredited

And as of 17 December 2013, the medical device industry has a new option from which to obtain a UDI.

In a statement, GS1, a standards organization, announced that FDA has accredited the company to assign UDI numbers.

GS1's UDI standard, known as the Global Trade Item Number (GTIN), is already widely used throughout various industries, including the medical device industry.

"Healthcare manufacturers in the US and around the world can create and maintain UDI numbers (i.e. GTINs) by following the requirements of the FDA UDI Rule and the GS1 General Specifications," the group said in a statement.

The company has set up a website to assist manufacturers wishing to use the standard to maintain UDI compliance.


GS1 Statement


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