Posts Tagged ‘GS1’

FDA UDI Regulations – An Updated Look at the Timeline

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!

IQPC Pharmaceutical Serialization and Traceability 2011 – Geneva

We are looking forward to attending IQPC’s Pharmaceutical Serialization and Traceability conference coming to Geneva in November. The conference will focus on topics that are very important to us, such as patient safety and anti-counterfeiting.
One of the featured speakers for the event, Janice Kite, Director Healthcare Traceability for GS1, participated in our “Tips for Implementing FDA UDI without Derailing Production” webinar. At the Geneva event, Janice’s presentation, “Traceability and Product Serialization Standards and Harmonization”, will cover key worldwide regulatory and industry developments, GS1 Standards for Healthcare, how GS1 standards assist in compliance to the Directive for Falsified Medicines and the standardization strategy across Europe and Internationally.
The conference will also have industry speakers from the EFPIA, APB and PGEU, GIRP and HIBC as well as from manufacturers AstraZeneca, Roche, Boehringer-Ingelheim, GlaxoSmithKline, Daiichi-Sankyo and Abbott Laboratories.
If you are planning to attend this event, be sure to use ‘19085.002Prisym’ to get a 20% discount on the standard conference prices. You can register in one of three ways:

Go online: http://www.pharmaserialisation.com/Prisym
Call: +44 (0)207 368 9300
Email: enquire@iqpc.co.uk

HIBC or GS1- Which Way Should We Go?

There’s been an ongoing debate regarding two barcode systems for medical products, HIBC and GTIN from GS1. There’s a school of thought that the industry needs to standardize on one system. But which option is better? And do we really need to pick just one? (more…)

GS1 – Increase Efficiency, Reduce Costs & Increase Patient Safety

GS1 adoption is vital as life sciences and healthcare companies focus on reducing operating costs and increasing efficiency. Software companies are rising to the challenge as the life sciences industries focus on reducing operating costs and increasing efficiency in these tough economic times.

What is GS1?

GS1 aims to improve efficiency and traceability through the supply chain by providing a global system of identification and communication standards. It is the most implemented supply chain standards system in the world. (more…)

Top Healthcare Providers Support GS1 Standards Adoption Dates

As part of the ‘GS1 Standards for Healthcare Working Group’ we are encouraged to see so many of the top US healthcare providers supporting adoption dates for the GS1 standards and proactively endorsing the standards to their suppliers.

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