FDA issues Unique Device Identification final rule
The Food and Drug Administration (FDA) on September 24 published the final rule for its Unique Device Identification (UDI) system to provide a consistent way to identify medical devices throughout their distribution and use. “A UDI system for medical devices is an important step towards increasing patient safety, modernizing postmarket…
ORs could see benefits from FDA's UDI system
Your OR could see real benefits from the Food and Drug Administration’s (FDA) proposed unique device identification (UDI) system. But will your systems be ready to capture, record, and retrieve UDI information? Comments on the FDA’s UDI proposed rule are due by November 7, 2012. The proposal was published July…
FDA proposes a UDI system for medical devices
The US Food and Drug Administration (FDA) released its long awaited proposed rule for a unique device identification (UDI) system on July 3, 2012. Comments will be accepted for 120 days after the proposed rule is published in the Federal Register, which was expected in early July. The rule would…
FDA issues notice regarding the Steris System 1 processor
The Food and Drug Administration (FDA) in a December 3, 2009 notice outlined regulatory concerns about the Steris System 1 processor and recommended that facilities make a transition to alternative products as soon as possible. In the notice, the FDA says Steris has "significantly modified" the Steris System 1 over…
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