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On November 16, 2017, the FDA released a final guidance to assist industry and FDA staff in understanding the Agency’s requirements for direct marking of medical devices for device identification purposes. Among other requirements, the Unique Device Identification System Rule (UDI Rule) requires the label of most medical devices to include a unique device identifier (UDI). Also, according to 21 CFR 801.45, any device required to bear a UDI on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

The final guidance aims to increase the industry and FDA staff’s understanding of direct marking requirements by defining terms used in the Agency’s regulations, including how FDA interprets the term “intended to be reprocessed,” and further explaining other aspects of UDI direct marking.

On Thursday, November 30, 2017, the FDA hosted a webinar for industry to discuss and answer questions about this final guidance. FDA employees were welcome to participate in this webinar and may join in listen-only mode. No registration is required.

Target Audience: Industry

For more information about the Unique Device Identification System, please visit the FDA’s UDI webpage. If you have any questions, please contact the FDA UDI Help Desk.