FDA issues final rule on unique identification system for medical devices

FDA has announced its final rule for a unique device identification system that will help to locate medical devices and improve patient safety as well as assist the FDA in identifying problems and issue targeted recalls.“[Unique device identification] UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, stated in a press release.

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