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UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?

This article was originally published in The Gray Sheet

Executive Summary

FDA’s requirement that high-risk devices bear distinctive identifiers has come and gone, yet some industry experts say there are firms still struggling to determine the type of product data they need to feed into the agency’s Global Unique Device Identification Database. “Collecting data attributes is the hardest part of implementing UDI, by far,” says UDI guru Jay Crowley.


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