UDI Impact on Medical Device Labeling: Lifting The Lid On Pandora's Box

By Cathi Crist and Stephen Birtsas

Medical device companies are striving to capitalize on market opportunities while simultaneously dealing with increasing regulatory compliance requirements. One of the newer mandates, the FDA ruling on Unique Device Identification (UDI), requires action in three main areas:

• Label & Packaging
• Direct Marketing (DM)
• UDI Database

While working to comply with the rule, manufacturers have realized that the problem to be solved is multi-faceted and interconnected. It’s like the ancient Greek myth of Pandora opening the box releasing the not-so-pleasant things into the world. Although kinder to the industry than originally anticipated, the FDA’s UDI ruling is more complicated than just a labeling change, making implementation a challenge.

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