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UDI for Medical Devices

Unique Device Identification (UDI) – Inside the Final Rule

The FDA recently released its final rule on Unique Device Identification (UDI) for medical devices. Here’s some information on the new rule and how it could affect you. Background UDI is unique identification applied to medical devices.  If you are a supplier of medical devices, you can adapt to UDI fairly easily with in your …

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UDI Conference Sheds Light on Pending FDA Medical Device Labeling Regulations

On September 18 and 19, 2012 the FDA sponsored the 2012 Unique Device Identification (UDI) Conference in Orlando, FL. The conference marked the final call for comment on the UDI proposal to develop a unique item identification standard for medical devices. Expected to take effect in May of 2013, the ruling would require all medical …

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FDA Proposes Rule on Unique Device Identification (UDI) for Medical Devices

In July 2012, the U.S. FDA announced its proposed regulatory language for a Unique Device Identification (UDI) system for most medical devices distributed in the United States. Based on legislation passed in September 2007, this proposal would establish a unique and uniform labeling system to identify U.S. medical devices throughout the supply chain, from manufacturer …

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