Regulatory Focus™ > News Articles > Third Company Obtains Accreditation Under FDA's Unique Device Identification Program

Third Company Obtains Accreditation Under FDA's Unique Device Identification Program

Posted 18 February 2014 | By Alexander Gaffney, RAC 

Medical device manufacturers now have a third accredited option from which to ensure compliance with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, regulators announced last week.

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.

Accredited Bodies

As of January 2014, just two outside entities had obtained accredited status from FDA: GS1, which administers the Global Trade Item Number (GTIN), and the Health Industry Business Communications Council (HIBCC), which administers the Supplier Labeling Standards (SLS).

Now FDA has announced that a third firm, the International Council for Commonality in Blood Banking Automation (ICCBBA) has obtained accredited status. The group is responsible for the ISBT 128 standard, used for blood and transplant products.

The company's accreditation status is good through 12 February 2017, FDA said.

FDA's UDI webpage.

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