By Linda Rouse O’Neill
Vice President, Government Affairs
Linda Rouse O’Neill
How well do you know and understand the Food and Drug Administration’s (FDA) unique device identifier (UDI) rule? This is a significant UDI month for healthcare distribution, since September 24 is the class II medical device deadline for UDI label and packaging implementation. While manufacturers of these devices should already be prepared for this second significant UDI checkpoint, now’s the time for all trading partners to be actively following ongoing rule developments and discussing both current and future labeling responsibilities.
The following are key points related to UDI:
- A UDI is a series of numeric or alpha numeric characters required by the FDA on a medical device label, its packaging, or directly on the device itself.
- The FDA’s final UDI rule, released in 2013, set the foundation for UDI use across healthcare for operational, financial, clinical and, post-market surveillance purposes.
- The FDA’s intent is for almost every medical device to be tracked down to patient use, with few exceptions.
Class III medical device labels and packaging have required UDIs since September 2014, but that deadline may not have affected you or your customers directly if you don’t deal with those products on a regular basis. As we now get further into the rule’s implementation, it applies to products that are much more prevalent across healthcare settings.
Label and Packaging Implementation Timeline
- September 2014: Class III medical devices (products posing the greatest potential risk to patients; pacemakers, heart valves, and stents, for example)
- September 2016: Class II medical devices (moderate potential patient risk; infusion pumps, surgical needles, power wheelchairs)
- September 2018: Class I medical devices (least potential patient risk; tongue depressors, elastic bandages, gloves)
- September 2020: Reusable/reprocessed devices not classified as I, II, or III
Distribution pain points
Both distributors and manufacturers need to understand UDI requirements. That’s because the rule as currently written exempts single use devices (SUDs) from labeling requirements if they are sold as part of a larger package. But if a distributor breaks down packages and sells SUDs individually, perhaps as part of low-unit-of-measure (LUM) inventory programs, the FDA could determine the distributor must add a UDI to those smaller package units.
In June, HIDA and several distributor members met with FDA and other government officials to discuss this issue and other challenges associated with class I and II UDI labeling requirements. HIDA has asked Congress for an extension allowing the FDA to clarify key questions about its rule. It’s uncertain whether that extension will happen, which is all the more reason why every supplier should be working on their UDI strategy now, even if they sell only class I devices. After all, 2018 is only two years away.
Since the FDA is still determining the full implications of how its rule affects potential class I and II device relabeling requirements for distributors, this is a top-of-mind issue for HIDA and should be for you as well. It’s not too late to ask what you can do right now to prepare for this month’s deadline.
HIDA Government Affairs can answer any of your most pressing UDI questions. Simply email us at HIDAGovAffairs@HIDA.org and we’ll be sure to help.