por Loren Bonner
, DOTmed News Online Editor | February 03, 2014
The deadline for manufacturers to comply with the U.S. Food and Drug Administration's Unique Device Identification (UDI) will be here sooner than we know it — and there is still a lot of work to do. Karen Conway, executive director of industry relations for the supply chain consulting firm GHX, explains the progress and challenges of the rule so far.
FDA issued the final UDI rule on Sept. 24, 2013 and the first compliance deadline is this year, on Sept. 24. UDI is a two-part system that involves a bar code as well as human-readable text on medical devices, with the aim to manage materials better and improve the quality and safety of existing medical devices and those coming to market.
DMN: The final rule passed, what's the next step for manufacturers?
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Manufacturers are very busy — especially those who have class III devices, because they will have to comply with the UDI rules by September 24th [this year]. They need to be assigned a UDI compliant code, like a global trade item number. Manufacturers need to label their products with that code in both a human- and machine-readable form, and they have to have published data to the Global UDI Database (GUDID).
DMN: It sounds like a lot of work.
There are some who have been working on this for a long time and others who got started soon after the rule came out. It's definitely hard work.
A year after this deadline [Sept 24, 2014], the next category of products that will need to comply are those described in the FDA Safety and Innovation Act as "implantable, life-saving, and life sustaining" — mostly class II devices — they will have to comply by Sept. 24 of 2015 and then the rest of the class II devices in 2016, and then in 2018 it is all non-exempt class I devices. Some products — those that are intended to be used more than once and reprocessed before each use, must also have direct part marking (DPM). For most products, the DPM deadline is two years after their initial compliance date, except for products that are "implantable, life-saving, and life sustaining," which must be in full compliance by September 24, 2015.
DMN: What do you think the biggest challenge is right now for everyone involved in this?
First, lots of education needs to happen in various manufacturing functions — it's much more than a labeling exercise. You have to have multiple functions involved and pull the right team members together who can identify which products fall into which compliance deadlines, then publish product attributes to the GUDID. But those attributes often sit in different locations, formats, and systems and they are owned by different functions and people, so you have to figure out where all this data is — one might have some of it in an Excel sheet, or some in the master data management system. You have to figure out where it is and how to harvest it. How are you going to get it ready to publish to the GUDID? And most important, you have to create sustainable processes — it's not something you do once — because if you create new products, significantly enhance them, or acquire new products, they need to have UDIs and be in compliance with the regulation.