Tag: FDA
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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