UDI Compliance - Further Draft Guidance Issued By FDA

Back to NAM Blog

UDI Compliance - Further Draft Guidance Issued By FDA

UDI Compliance - Further Draft Guidance Issued By FDA

On July 25, the FDA issued further draft guidance for identification tags designed to track medical devices, such as pacemakers, from the manufacturer all the way down to the user.  It is anticipated that come this fall the number of medical devices that will be required to meet tracking regulations will increase.

 
UDIs, or unique device identifiers, indicate specific model and data information on as many as five elements in the production process. For instance, some of these elements may include expiration dates, serial numbers, and manufacturing dates of the device. Requirements for these medical devices are being phased in by the Food & Drug Administration for the purpose of better tracking.  
 
According to the most recent guidelines, the UDI is required in plain-text version as well as an automated version that can be added to a computer system such as a patient's electronic health record or even billing/insurance claims.  In the UDI rule issued by the FDA in 2013, there was no requirement for an automated identifier to be created by a specific technology or in a specific form.  However, these most recent guidelines specify the automated marker needs to be in a format that allows for reading by such technologies as barcode scanners.
 
Automated markers may be broken up into multiple segments for devices and/or packages where space is limited according to the guidance; however, specific model information must come before production information.  
 
The UDI tracking system is intended to roll out over a seven year time period, and is currently in the third year.  At this point, UDIs must be included on the device itself and packaging for devices intended for more than one use including life-supporting, life-sustaining, and implantable devices.  Class III devices are currently required to include UDIs on packaging, however by September 24 it will be required that a UDI be on the device itself. Class III devices are those with the highest risk, such as pacemakers.
 
At Markem-Imaje our proven medical device experience allows us to provide the right technology to ensure UDI compliance and meet your UDI printing specifications.  As a coding and marking solutions manufacturer, you can count on our team to assist with meeting UDI regulations.

January 10, 2014
Markem-Imaje Announces Acquisition of CSAT

Markem-Imaje Announces Acquisition of CSAT
Back to top