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!

UDI aims to reduce medical errors involving medical devices by:

• Providing a single, globally-accepted source for positive identification of medical devices
• Ensuring the adequate identification of the device through its distribution and use
• Providing rapid access to key attributes relating to the device
• Simplifying integration of information on device use into medical records
• Providing a means of added depth to patient and physician educational materials without adding greater complexity

UDI also aims to provide for more rapid resolution of device problems by:

• Making it possible to more rapidly identify devices involved in adverse events
• Providing for more rapid resolution of confirmed problems
• Provide a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices
• Meet other Federal agencies’ needs for a single, consistent means of identifying medical devices
• Reduce the costs of moving medical devices in international commerce

Who is it Relevant to?

UDI is relevant to any organisation working in or supplying medical device products to the US. Where can I find out more about UDI? Visit www.fda.gov for more information.

Prisym Medica Labeling Software:

PRISYM Medica labelling software is a purpose designed labelling solution for Life Science organisations that need to meet the FDA’s labelling regulations. Medical device companies can easily implement UDI utilising the PRISYM Medica Solution. PRISYM Medica is supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.