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The Food and Drug Administration (FDA) UDI system is being phased in over several years. The first sunrise date (certain Class III devices) occurred 09/24/14. Recognizing UDI implementation will take time, healthcare supply chain and risk management professionals should be aware of already-implemented changes in the FDA’s adverse event reporting methodology. One of the changes required immediately is the use of the UDI in adverse event reporting.

The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:

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