FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Extends UDI Deadlines Another Two Years for Class I, Unclassified Devices

Nov. 14, 2018

The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique device identification system requirements, which are being phased in over seven years.

The agency said it decided to focus on addressing existing implementation challenges for higher-risk devices before focusing on implementing UDI for lower-risk devices.

In guidance released Nov. 2, the FDA said the new compliance date for direct mark requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices is Sept. 24, 2020.

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