Last month the FDA released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”, intended to help medical device labelers understand the FDA’s requirements for direct marking of devices for unique device identification purposes.
A unique device identifier (UDI) is required to be directly marked on a device itself if the device is required to bear a UDI on its label, and is also intended to be used more than once and reprocessed before each use. Because these devices are typically separated from their original labels or packages bearing UDIs, directly marking them with a UDI assures adequate identification.
Upcoming UDI compliance dates are:
- Class I, class II, and unclassified implantable, life-sustaining, or life-supporting devices must comply with the UDI labeling and GUDID submission requirements by September 24, 2015.
- All life-sustaining or life-supporting devices must comply with the UDI direct marking requirements by September 24, 2015.
Lernia is now offering an eLearning course that will help you become familiar with the dynamics involved in the medical device industry when implementing the Unique Device Identification regulations. Course lessons include:
- History of UDI Regulations
- Classification of Medical Devices
- Key UDI Principles and Compliance Deadlines
- Overview of GUDID
- Key Implementation Questions
For more information, and to purchase a copy of our UDI eLearning course, visit our Products page.