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Focus on Regulation

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices.  Under the planned guidance, devices in these categories will now have an additional two years to comply with labeling, GUDID data submission, and standard date formatting requirements pursuant to a new compliance deadline of September 24, 2020.  The notice also states that until September 24, 2022, the agency will apply its enforcement discretion to the direct marking requirement deadline for reusable and reprocessed devices falling within these class I and unclassified categories of devices. Implantable, life-supporting, or life-sustaining devices that are unclassified or class I are excluded from the extension because the compliance date for those devices, September 24, 2015, has already passed, thereby necessitating compliance with UDI requirements.

This notice is the latest in a series of extensions that have been granted to specific industries and classes of devices as manufacturers have encountered compliance issues.  FDA previously granted extensions or alternative labeling arrangements for implants intended to be sterilized prior to use, contact lenses, convenience kits, and devices sold at retail and marked with UPC codes.

The agency is continuing to work to finalize its draft guidance about UDI labeling requirements for convenience kits and surgical trays, as well as direct marking requirements for reusable devices that are reprocessed between uses. FDA expressed its intent to engage with industry and other stakeholders as it seeks to optimize the existing UDI system and resolve implementation issues, and promote the smooth future integration of class I and unclassified devices into the UDI system.