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What to expect in 2015 from the FDA’s UDI Final Rule

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Argos Multilingual

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21 Apr 2015

It may just seem like yesterday that you began preparations to change your multilingual content in accordance with the FDA’s UDI Final Rule Phase I. No sooner having closed that chapter, the next has begun requiring even more changes to labeling and packaging content. September 24, 2015 will come sooner than you think!

Let’s recap UDI Final Rule. The FDA requires that a unique device identifier is included on all labeling and packaging of medical devices. This initiative is being implemented over the course of several years to help make this process as easy as possible for medical device manufacturers and labelers to comply with.  Phase I required that all class III devices and PHS Act devices comply with this rule by September 24, 2014.

Now that Phase I has come and gone, medical device manufacturers and labelers are now being faced with Phase II, requiring all labeling and packaging content for implantable, life-supporting, and life-sustaining devices and stand-alone software (that is life-sustaining or life-supporting) to have this same UDI. This UDI must be clearly readable by both humans and machines alike. 

Included within UDI Final Rule Phase II, the DI (Device Identifier) and data for these qualifying devices must then be submitted to the GUDID (Global UDI Database) database, a public database that will track and reference all devices that have a UDI.  This database will allow information surrounding the device to be both searchable and accessible providing instantaneous visibility into the history of that specific device.  

Having spoken about Phase I early last year with our life science localization thought leader, Shannon Rose Farrell, we thought it would be a good opportunity to gain a little more insight into the effects of Phase II from a localization point of view.

A: What are some of the added benefits of UDI Final Rule that medical device manufacturers can capitalize on regarding their global content?

SRF: As with any change that takes place within the life science industry, there are usually significant efforts that have to take place in order to see these changes through to implementation and validation. Due to the rigorous demands and regulations of this industry, many much-needed changes get pushed to the wayside as painful workarounds and temporary processes are put into place.  With regulatory changes such as UDI Final Rule, this can be an opportunity to bring some of those other, much-needed changes forward to implementation while the content is already open for changes and review.

In addition, UDI Final Rule may be forcing some of your internal processes to be re-looked at.  While these processes are open and changing, it may be time to implement efficiencies surrounding your global content lifecycle.  Using this rule as a catalyst for process efficiency and change can be a very powerful tool.

A: What is one piece of advice you can give to medical device manufacturer’s facing this change regarding their global content?

SRF: Understand the impact this will have on your global content.  First and foremost taking inventory of all the content this rule will effect is extremely important.  Next, it is key to determine who will need to be involved in order to meet this deadline and what processes need to be put into place.  From there, you can have a plan of attack to finally meet the UDI Final Rule deadlines and get your global content up to par.

One additional piece of advice… don’t hesitate to reach out to your life science localization partner, we are always there to help you through these times of change. 

A: What kind of language service provider should life science companies be looking for to help them through this type of regulatory change?

SRF: Experience. It may sound simple but this is the true differentiator here. A life science company going through this type of regulatory change needs a not just a Language Service Provider but also localization partner that can help work as an extension of their team, being there every step of the way until the goals and deadlines are met.  The localization partners that I’ve seen succeed and that stand out are those who go one step further and have knowledgeable industry leaders who can take your unique situation and help you plan a path towards success. Regulatory changes are never easy and that is why an experienced localization partner, who understands your industry and who can be your trusted advisor throughout this process is the one who will ultimately become your long-time global content partner.

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