Article preview from "The Gray Sheet" - November 12, 2012
Device industry groups are calling for FDA to extend the timeframes for requiring unique device identifiers on all products to allow firms more time to prepare, while hospitals are urging a shorter implementation timetable to enable earlier use of the system to track devices and recalls.
Article preview from "The Gray Sheet" - November 12, 2012
Device firms are asking FDA for more time to implement a new mandatory unique device identifier system, while hospital groups counter that the agency’s UDI proposal envisions too long of a transition period for manufacturers.
FDA received more than 100 public comments on its UDI proposed rule, which were due Nov. 7. The draft rule, issued in July, maps out a system of products matched to unique codes that the agency claims will be crucial to the future of post-market safety surveillance, medical device adverse event reporting, recall management and safety alerts.
The agency has said it aims to finalize the proposed rule in the next six months, according to a timetable mandated by the FDA Safety and Innovation Act signed into law this summer. However, during a conference in September, Jay Crowley, CDRH’s senior advisor for patient safety, expressed some doubts on meeting the six-month timeframe.In written comments, industry signaled general support for the UDI proposal, but took issue with time deadlines by which companies will have to incorporate the UDI codes on devices and device packaging.
AdvaMed, for instance, requested a one-year extension for implementation of UDIs on device packaging/labeling for high-risk, class III devices.
FDA’s proposed rule states that class III devices will be required to include a UDI code on product packaging one year after publication of the final rule.
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