Knowledge Center

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:

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.