Labeling medical devices packages is difficult. At the same time as manufacturers are looking to shrink packages to save on materials and shipping, they are also adding languages to reach new markets.
This challenge of fitting more and more languages on products, particularly small ones, just got more challenging for medical device manufacturers: The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. The new labeling requirements will be included in 21 CFR Part 801 (Labeling).
An article in IVD Technology provides a detailed look into the history of UDIs and implications for medical device manufacturers. The article, UDI and You: What FDA's Proposed Rule Means for IVD Manufacturers, clearly demonstrates the challenges for device manufacturers: how to integrate UDIs into their global labeling strategy.
Since the UDI adds another element to already crowded labels and because expiration dates now will have to follow a U.S.-specific format (e.g., "JAN 1, 2103"), a one-size-fits-all global labeling strategy will no longer work.
Naturally, FDA is aware of this and is working with the International Medical Device Regulators Forum (IMDRF) to update the relevant old Global Harmonization Task Force document. IMDRF, for it's part has recently released version 2.0 of its proposed draft of UDI System for Medical Devices [PDF link].
While manufacturers have between one and five years to implement the rule (depending on device class), many medical device are already working furiously to modify labeling systems, SOPs, and, of course, multilingual labeling strategies.
[Hat tip to Mel Faux!]
For more about device labeling, take a look at some of our past articles:
- In device labeling, necessity breeds creativity
- Why IFUs need to be translated
- Becton, Dickinson gets labeling right
ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.