Unique Device Identification Proposed Rule
MedSun: Newsletter #75, August 2012

FDA - Medical Devices

The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.

Additional Information:

FDA - Medical Devices. Unique Device Identification Proposed Rule. July 13, 2012.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm


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