News Feature | August 8, 2016

FDA Issues Draft Guidance For Device UDIs

Christine Kern

By Christine Kern, contributing writer

FDA Healthcare

New guidance clarifies the medical device tracking rule.

The Food and Drug Administration has issued draft guidance designed to clarify the form and content of special tracking labels for medical devices, called UDIs. Specifically, unique device identifiers must appear in both plain text and a scannable automated identification and data capture (AIDC) version that could be included in a patient’s EMR.

The previous UDI rule, issued in 2013, did not require a specific form for the automated identifier, nor did it require particular technology to provide it. The new guidance specifies that the automated marker must be barcode scannable or use similar technology, The Hill reported.

The proposed guidance explained, “The UDI Rule is intended to create a standardized identification system for medical devices used in the United States. This system makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. In order for there to be an effective identification system, it is essential that the FDA-accredited issuing agencies develop and operate systems for the assignment of UDIs that allow labelers using these systems to be in compliance with UDI labeling requirements.”

The guidance comes as manufacturers and labelers of Class II devices, such as contact lenses and ultrasound scanners, are gearing up to comply with the package labeling requirements this fall. 

Last year, the FDA launched its Global Unique Device identification Database (GUDID) which serves as a resource to report adverse effects of devices and hasten reactions to recalls. As the FDA explained, “Medical devices cover a wide range of products — implants, CT scanners, surgical instruments, contact lenses, wheelchairs, and blood glucose tests, to name a few. Unlike drugs, many medical devices currently do not have a unique identifier that clearly distinguishes one product from another. But this is changing. The UDI system will provide a consistent and standard way to identify medical devices throughout their distribution and use by healthcare providers and patients.”

The UID tracking system is beneficial when identifying devices that are problematic and notifying other users of those devices, as was the case with the recent recall of Olympus duodenoscopies after the FDA issued a warning that the scopes were difficult to clean and had led to a rash of life-threatening infections.

The draft guidance will be open for public comment for 60 days.