In June 2010 PRISYM ID hosted a webinar titled, “Tips for Implementing FDA UDI without Derailing Production”. Featured speakers included Jay Crowley from the FDA and Janice Kite from the GS1 Global Office. The webinar gave an overview of UDI (Unique Device Identification) in practical terms and went through the planned timeline for proposed FDA UDI regulations.

Now that a year has passed, we thought it would be beneficial to provide you with an updated timeline around FDA UDI. While nothing is official, the following is the most recent information on how the FDA UDI rollout might look:

12 Months after the FDA UDI Standard is Published (2013)

The first set of deadlines focus on Class III Medical Devices. These are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient, such as implantable pacemakers, replacement heart valves, automated external defibrillators, and implants.

• UDI will apply to all levels of packaging
• An engraved UDI may be required for some Class III medical devices
• If a device has a serial number, the UDI will also be serialized

36 Months after the FDA UDI Standard is Published (2015)

The next class of medical devices to be effected is Class II, which are items like x-ray systems, gas analyzers, pumps, and surgical drapes.

• UDI will apply to all levels of packaging

60 Months after the FDA UDI Standard is Published (2017)

The final group is Class I Medical Devices, such as tongue depressors, arm slings, examination gloves, and hand-held surgical instruments.

• UDI will probably just apply to the device (not packaging)

Medical devices are classified by intended use and potential risk to the patient, and as you can see from the timeline above, the UDI regulations address the most critical devices first. The years listed are based on the FDA UDI standard being published in 2012, which is the current plan. Stay tuned!