In September 2013, Congress enacted the FDA Amendment Acts of 2007, including the Unique Device Identification (UDI) rule requiring that manufacturers label their products at each packaging level with human and machine readable codes. These codes will uniquely identify the product, and will include production data, such as lot and serial number and expiration date.
As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. The Unique Device Identification rule represents a major step in improving patient safety, modernizing our post-market surveillance system for medical devices, and facilitating medical device innovation.
UDI Overview Course – eLearning
Lernia Training Solutions has recently completed an eLearning module that introduces medical device colleagues to the recently approved guidance from the FDA regarding UDI. The 20-minute module will help you become familiar with the dynamics involved for the medical device industry, and key considerations that an organization should know when implementing the UDI regulations.
By the end of the course, you will be able to:
- Recognize the origin and historical timeline of UDI regulations for medical device manufacturers
- Explain the different classifications of medical devices
- Identify key UDI principles and compliance deadlines for implementation of UDI in your organization
- Recognize general submission requirements to the Global UDI Database
- Discuss key considerations when planning the adoption of UDI across your company
UDI eLearning Sample
This video clip provides a brief glimpse of the training module.
The full UDI course is available for purchase in our Products catalog. Stand-alone and source code versions are provided.
For More Information …
We are currently developing additional eLearning modules on specific UDI topics. Please contact us if you are interested in learning more about these upcoming modules.
If you are interested in customization of this UDI Overview module for your organization, or want to learn more about other training topics that are offered by Lernia, please fill out the Contact Us form and check the UDI box, or call 610.356.1792.