The Global Language of Business

US FDA considering to extend the last compliance date for UDI

The US FDA released a letter to communicate its intent to extend the UDI compliance dates for class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, for a period of two years. During this time, the FDA plans to engage with industry and other stakeholders to address existing challenges and optimise the quality and utility of the data for higher-risk medical devices already in the UDI system before adding lower-risk medical devices. This letter only expresses the FDA’s intent to extend and a formal guidance will be issued in the near future.