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Medical Devices to Require Unique Identifier Under New FDA Rule

Monday, September 23, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule that will require the labels of most medical devices distributed in the U.S. to include a unique device identifier. Each UDI will consist of a device identifier, which corresponds to the specific version or model of the device and the labeler, and a production identifier that provides variable information such as the lot or batch, serial number, expiration date and date of manufacture.

This rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture technology. The UDI must be directly marked on the device itself if the device is intended to be used more than once and to be reprocessed before each use. In addition, labelers must submit product information concerning affected devices to the FDA’s Global UDI Database unless subject to an exception or alternative.

The FDA states that by making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, this rule will reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. It is also intended to allow the FDA, health care providers and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused corrective action.

The FDA is phasing in the requirements of this rule over seven years, beginning Sept. 24, 2014. This approach is intended to provide labelers, the FDA and the health care community adequate time to build and test the systems and infrastructure needed to implement the rule’s requirements and to spread the costs and burdens of implementation over time.

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