All systems go as US deadline for UDI medical device rule approaches

摘要

Momentum is gathering in the US around the imminent introduction of a rule that will require most medical devices distributed in the country to carry a unique device identifier (UDI), The legislative deadline for the Food and Drug Administration to finalize the UD! rule it proposed in July 2012 is just months away.The agency is now on the final leg of dealing with the "thousands of pages of comments" it received during consultations with stakeholders, many of whom expressed concern over the practicality, usability and cost implications of certain provisions in the proposed rule.