Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA amends UDI proposed rule. Comments sought on pre-market approval exemption for custom devices. More regulatory news.
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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.
Regulatory News In Brief
International draft guidance on a single-audit program for device facilities is expected out by the end of the month, ECRI weighs in on UDI proposed rule, and more regulatory updates.