International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Global UDI guidance
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UDI By December? FDA Confident On Year-End Release Of Proposed Rule
FDA expects to lay out a proposed framework for mandatory unique device identification in December, though a final rule is at least a year away, according to Jay Crowley, senior advisor for patient safety at FDA.
FDA, AAMI Form Action Plan, Safety Council To Fix Infusion Pump Problems
FDA and the Association for the Advancement of Medical Instrumentation are launching an infusion device safety council to help implement improvements to infusion pump safety
GHTF Releases Long-Awaited Corrective, Preventive Action Guidelines
New guidance from the Global Harmonization Task Force lays out a detailed, four-phase approach to corrective action and preventive action programs within device quality management systems