FDA UDI Resources

There is a lot of information on the FDA Unique Device Identification program scattered around the web and I thought it would be a good idea to post links to some of the best resources – I started this more my own benefit, but it might help others with an interest in this topic.

If you are in the medical device supply chain, you’ll be aware that the FDA is in the process of developing its rule for the unique labeling of devices and an associated database that will manage all of the information. Medical device manufacturers and packers will have an obligation to mark each device they make and ship as well as upload all the pertinent information to the database.

So where to start finding good information?

Dare I say that here at Labeling News is a good spot. We have (at the time I wrote this in April 2013) nearly 50 articles that mention the FDA UDI program – see them in all in this Google Search. We’ll be adding new UDI content in the future as well, so check back here from time to time if you can.

Want to get some information right from the source? Over on the FDA site there is a section devoted to UDI – check it out: FDA UDI Info. You can also get your copy of the Final Rule for the FDA site.

Are you a LinkedIn user? If you are, you might want to sign up for the UDI group. So far there isn’t a huge amount of activity there, but as we closer to UDI becoming a reality I’m sure the pace will pick up. Some of the members who post in the group are very knowledgeable so it is well worth keeping an eye on what is happening there.

Excellent sources of information are the two competing standards organizations that are staking their competing claims to be the UDI system of choice.

GS1 is rapidly become the “go-to” organization for tracking and traceability in many industries Worldwide. A good place to start is the GS1 Healthcare Homepage. There is also a whitepaper on UDI produced by GS1. See it here: GS1 UDI Whitepaper

The other standards organization competing in this sector is Health Industry Business Communications Council (HIBCC). The HIBCC is already firmly established in the Medical Device industry and their barcode system certainly seems to have some advantages over the GS1 alternative – the fact that it is alpha-numeric so that actual product numbers can be used is a big plus and RFID is neatly implemented – but GS1 seems to have the momentum, because of the huge GS1 presence in global supply chains.

Like GS1, HIBCC has section on their website dedicated to UDI – HIBCC UDI Center

Here at Winco ID we have already helped some of our medical device customers with implementing GS1 or HIBCC barcoding in order for them to get a head start on UDI. Having unique identification for medical products makes a lot a sense, even without the regulatory requirement.

We can help your company as well – from durable pressure-sensitive labels, label printers, GS1 and HIBCC label templates for BarTender, Laser marking systems to barcode scanners, there is a lot we can do to help.

If Winco ID can help your company, give me a call at 603-598-1553 x237. Also, if you have any links to great UDI resources, please post them in the comments below.

Oh, don’t forget our FREE seminar, Ensure UDI Success! Coming up November 13th

Medical Device Manufacturers. Our half-day, free seminar focuses on how to meet the requirements of the FDA’s UDI mandate – labeling, direct marking, Automatic ID Technology using the GS1 or HIBCC, the GUDID and simplifying implementation. Details >>