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Industry, Hospital Groups Debate Implementation Deadlines For UDI Rule

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.

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,...

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