Device Manufacturers Get New Option to Ensure Compliance with UDI Rule

Posted 13 January 2014 | By Alexander GaffneyRAC

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 second 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.

Accreditation

On 17 December 2013, standards group GS1 became the first group to be recognized by FDA as being capable of assigning UDI numbers on its behalf.

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.

New Issuing Agency

But now members of the medical device industry will have a second entity from which to obtain UDI numbers and ensure compliance.

In a notice quietly posted to FDA's website in late December 2013, FDA announced that the Arizona-based Health Industry Business Communications Council (HIBCC) has been accredited as an "issuing agency" under the UDI rule.

As an issuing agency, HIBCC will be permitted to ensure compliance with the UDI rule and issue UDI numbers using its Supplier Labeling Standard (SLS) data format. In a statement, HIBCC said the standard is already recognized by both the International Medical Device Regulators Forum (IMDRF) and the European Commission (EC).

"HIBCC is pleased to be serving as an FDA-accredited Issuing Agency to assist the industry in efficient and comprehensive UDI implementation," HIBCC CEO Robert Hankin said in a statement.


FDA's UDI Page

HIBCC Statement


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