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FDA: Delayed UDI Compliance Date for Class I and Unclassified Devices

For lower risk devices, new compliance dates will extend into 2020 and 2022.

On Friday, June 2, Thomas P. Gross, MD, MPH, Director of the Office of Surveillance and Biometrics, CDER, penned a letter explaining that the agency plans to extend compliance dates for the unique device identification system (UDI system) requirements for certain class I and unclassified devices that generally present a lower risk to patients, such as manual surgical instruments and mechanical wheelchairs.

He acknowledged the need for robust integration of UDI data throughout the healthcare system, and announced plans “to engage with industry and other stakeholders to address existing challenges and optimize the quality and utility of the data for higher-risk medical devices already in the system before adding lower-risk medical devices.”

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